Frequencies for enfrep20150624 dataset : by Jean Roth , jroth@nber.org , 18 Dec 2015 Frequencies for producttype variable in enfrep20150624 dataset : Product | Type | Freq. Percent Cum. ------------+----------------------------------- Biologics | 19 28.36 28.36 Devices | 26 38.81 67.16 Drugs | 13 19.40 86.57 Food | 9 13.43 100.00 ------------+----------------------------------- Total | 67 100.00 Frequencies for eventid variable in enfrep20150624 dataset : Event ID | Freq. Percent Cum. ------------+----------------------------------- 68105 | 2 2.99 2.99 70164 | 1 1.49 4.48 70882 | 1 1.49 5.97 70974 | 1 1.49 7.46 71041 | 1 1.49 8.96 71077 | 1 1.49 10.45 71081 | 1 1.49 11.94 71108 | 2 2.99 14.93 71120 | 1 1.49 16.42 71132 | 1 1.49 17.91 71146 | 1 1.49 19.40 71153 | 1 1.49 20.90 71154 | 1 1.49 22.39 71155 | 1 1.49 23.88 71161 | 1 1.49 25.37 71219 | 1 1.49 26.87 71221 | 1 1.49 28.36 71224 | 1 1.49 29.85 71225 | 1 1.49 31.34 71226 | 1 1.49 32.84 71239 | 1 1.49 34.33 71247 | 1 1.49 35.82 71251 | 1 1.49 37.31 71253 | 1 1.49 38.81 71264 | 1 1.49 40.30 71266 | 1 1.49 41.79 71268 | 1 1.49 43.28 71276 | 1 1.49 44.78 71278 | 1 1.49 46.27 71284 | 1 1.49 47.76 71285 | 1 1.49 49.25 71293 | 5 7.46 56.72 71299 | 1 1.49 58.21 71301 | 1 1.49 59.70 71303 | 1 1.49 61.19 71304 | 1 1.49 62.69 71306 | 1 1.49 64.18 71310 | 2 2.99 67.16 71325 | 1 1.49 68.66 71329 | 1 1.49 70.15 71334 | 1 1.49 71.64 71343 | 1 1.49 73.13 71354 | 2 2.99 76.12 71355 | 1 1.49 77.61 71364 | 1 1.49 79.10 71369 | 1 1.49 80.60 71374 | 2 2.99 83.58 71375 | 4 5.97 89.55 71378 | 1 1.49 91.04 71398 | 1 1.49 92.54 71399 | 2 2.99 95.52 71405 | 1 1.49 97.01 71432 | 1 1.49 98.51 71483 | 1 1.49 100.00 ------------+----------------------------------- Total | 67 100.00 Frequencies for status variable in enfrep20150624 dataset : Status | Freq. Percent Cum. ------------+----------------------------------- Completed | 3 4.48 4.48 Ongoing | 48 71.64 76.12 Terminated | 16 23.88 100.00 ------------+----------------------------------- Total | 67 100.00 Frequencies for recallingfirm variable in enfrep20150624 dataset : Recalling Firm | Freq. Percent Cum. ----------------------------------------+----------------------------------- Allegiant Health | 1 1.49 1.49 American Health Packaging | 1 1.49 2.99 American National Red Cross Southeast.. | 1 1.49 4.48 American Natl Red Cross Mid Atlantic .. | 1 1.49 5.97 American Red Cross Blood Services | 2 2.99 8.96 Amerx Health Care Corp. | 1 1.49 10.45 AstraZeneca Pharmaceuticals LP | 1 1.49 11.94 BPL PLasma, Inc. | 2 2.99 14.93 Beaver-Visitec International Inc. | 5 7.46 22.39 Becton Dickinson & Co. | 1 1.49 23.88 Biomet, Inc. | 1 1.49 25.37 Blood Assurance Inc | 1 1.49 26.87 Boston Scientific Corporation | 1 1.49 28.36 Byrd Cookie Co | 2 2.99 31.34 CareFusion 303, Inc. | 1 1.49 32.84 Carter BloodCare | 2 2.99 35.82 Community Blood Center of Carolinas | 1 1.49 37.31 CooperSurgical, Inc. | 1 1.49 38.81 DCI Biologicals Carbondale, LLC | 1 1.49 40.30 Dr. Reddy's Laboratories, Inc. | 6 8.96 49.25 Driscolls Strawberry Associates | 1 1.49 50.75 Garber Ice Cream Company Inc | 1 1.49 52.24 HeartWare Inc | 1 1.49 53.73 Hill-Rom, Inc. | 1 1.49 55.22 Innovative Blood Resources | 1 1.49 56.72 Integra LifeSciences Corp. | 1 1.49 58.21 Intuitive Surgical, Inc. | 1 1.49 59.70 MRP, LLC dba AMUSA | 1 1.49 61.19 Medtronic Navigation, Inc. | 1 1.49 62.69 Michael Zakany LLC | 1 1.49 64.18 Mortara Instrument, Inc | 1 1.49 65.67 Neuro Kinetics, Inc. | 1 1.49 67.16 Neusoft Medical System Co | 1 1.49 68.66 Novartis Pharmaceuticals Corp. | 2 2.99 71.64 Ohm Laboratories, Inc. | 1 1.49 73.13 One Lambda Inc | 1 1.49 74.63 OneBlood, Inc. | 4 5.97 80.60 Phildesco Inc. | 1 1.49 82.09 Philips Ultrasound, Inc. | 1 1.49 83.58 Smiths Medical ASD, Inc. | 1 1.49 85.07 Stryker Instruments Div. of Stryker C.. | 1 1.49 86.57 Synthes, Inc. | 2 2.99 89.55 Texas Pack, Inc. | 1 1.49 91.04 Turkana Food Inc. | 1 1.49 92.54 Vidacare Corporation | 1 1.49 94.03 Walter L. Shepeard Community Blood Ce.. | 2 2.99 97.01 West-Ward Pharmaceutical Corp. | 1 1.49 98.51 Whole Food Market | 1 1.49 100.00 ----------------------------------------+----------------------------------- Total | 67 100.00 Frequencies for city variable in enfrep20150624 dataset : City | Freq. Percent Cum. ----------------+----------------------------------- Augusta | 2 2.99 2.99 Austin | 1 1.49 4.48 Batesville | 1 1.49 5.97 Birmingham | 1 1.49 7.46 Bothell | 1 1.49 8.96 Canoga Park | 1 1.49 10.45 Carbondale | 1 1.49 11.94 Charlotte | 1 1.49 13.43 Chattanooga | 1 1.49 14.93 Clearwater | 1 1.49 16.42 Columbus | 1 1.49 17.91 Deer Park | 1 1.49 19.40 Detroit | 1 1.49 20.90 Eatontown | 1 1.49 22.39 Houston | 1 1.49 23.88 Jacksonville | 2 2.99 26.87 Kenilworth | 1 1.49 28.36 Lake Park | 1 1.49 29.85 Louisville | 1 1.49 31.34 Lowell | 1 1.49 32.84 Miami Lakes | 1 1.49 34.33 Milwaukee | 1 1.49 35.82 Nashville | 1 1.49 37.31 Norfolk | 1 1.49 38.81 North Brunswick | 1 1.49 40.30 Orlando | 1 1.49 41.79 Pittsburgh | 1 1.49 43.28 Plainsboro | 1 1.49 44.78 Port Isabel | 1 1.49 46.27 Portage | 1 1.49 47.76 Princeton | 6 8.96 56.72 Saint Louis | 1 1.49 58.21 Saint Paul | 2 2.99 61.19 San Diego | 1 1.49 62.69 Savannah | 2 2.99 65.67 Shavano Park | 1 1.49 67.16 Somerset | 1 1.49 68.66 Sparks | 1 1.49 70.15 St Petersburg | 2 2.99 73.13 Suffern | 2 2.99 76.12 Sunnyvale | 1 1.49 77.61 Trumbull | 1 1.49 79.10 Tyler | 2 2.99 82.09 Waltham | 5 7.46 89.55 Warsaw | 1 1.49 91.04 Watsonville | 1 1.49 92.54 West Chester | 2 2.99 95.52 Wilmington | 1 1.49 97.01 Winchester | 1 1.49 98.51 Zanesville | 1 1.49 100.00 ----------------+----------------------------------- Total | 67 100.00 Frequencies for state variable in enfrep20150624 dataset : State | Freq. Percent Cum. ------------+----------------------------------- AL | 1 1.49 1.49 CA | 4 5.97 7.46 CO | 1 1.49 8.96 CT | 1 1.49 10.45 DE | 1 1.49 11.94 FL | 8 11.94 23.88 GA | 4 5.97 29.85 IL | 1 1.49 31.34 IN | 2 2.99 34.33 MA | 6 8.96 43.28 MD | 1 1.49 44.78 MI | 2 2.99 47.76 MN | 2 2.99 50.75 MO | 1 1.49 52.24 NC | 1 1.49 53.73 NJ | 11 16.42 70.15 NY | 3 4.48 74.63 OH | 2 2.99 77.61 PA | 3 4.48 82.09 TN | 2 2.99 85.07 TX | 6 8.96 94.03 VA | 2 2.99 97.01 WA | 1 1.49 98.51 WI | 1 1.49 100.00 ------------+----------------------------------- Total | 67 100.00 Frequencies for country variable in enfrep20150624 dataset : Country | Freq. Percent Cum. ------------+----------------------------------- US | 67 100.00 100.00 ------------+----------------------------------- Total | 67 100.00 Frequencies for voluntarymandated variable in enfrep20150624 dataset : Voluntary/Mandated | Freq. Percent Cum. --------------------------+----------------------------------- Voluntary: Firm Initiated | 67 100.00 100.00 --------------------------+----------------------------------- Total | 67 100.00 Frequencies for initialfirmnotificationofconsign variable in enfrep20150624 dataset : Initial Firm Notification of Consignee | or Public | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 1 1.49 1.49 E-Mail | 4 5.97 7.46 FAX | 8 11.94 19.40 Letter | 43 64.18 83.58 Other | 1 1.49 85.07 Press Release | 1 1.49 86.57 Telephone | 4 5.97 92.54 Two or more of the following: Email, .. | 5 7.46 100.00 ----------------------------------------+----------------------------------- Total | 67 100.00 Frequencies for distributionpattern variable in enfrep20150624 dataset : Distribution Pattern | Freq. Percent Cum. ----------------------------------------+----------------------------------- AK, CA, DC, FL, IL, ME, MT, NE, NJ, N.. | 1 1.49 1.49 AL, AR, CT, GA, MA, MD, MS, NC, NH, N.. | 2 2.99 4.48 AR, LA, OK, TX | 1 1.49 5.97 According to firm the distribution pa.. | 1 1.49 7.46 CA | 1 1.49 8.96 California | 2 2.99 11.94 FL | 1 1.49 13.43 Florida | 3 4.48 17.91 France; CA | 1 1.49 19.40 Kentucky | 2 2.99 22.39 Korea, Republic Of(South); GA | 2 2.99 25.37 MI | 1 1.49 26.87 Minnesota, North Carolina, Texas, New.. | 1 1.49 28.36 NC | 1 1.49 29.85 ND | 1 1.49 31.34 NJ via 1 distributor | 2 2.99 34.33 NJ, NY and PA | 1 1.49 35.82 Nationwide | 9 13.43 49.25 Nationwide Distribution | 1 1.49 50.75 Nationwide Distribution including KY,.. | 5 7.46 58.21 Nationwide to wholesalers for further.. | 1 1.49 59.70 No US distribution. Worldwide Distrib.. | 1 1.49 61.19 Product was shipped to OH & MD | 1 1.49 62.69 TX | 1 1.49 64.18 Tennessee | 1 1.49 65.67 Texas | 2 2.99 68.66 U.S. distribution to the following; C.. | 1 1.49 70.15 US Distribution to the states of : C.. | 1 1.49 71.64 US Distribution to the states of : NC.. | 1 1.49 73.13 US Nationwide | 1 1.49 74.63 US Nationwide Distribution | 1 1.49 76.12 US and Mexico | 1 1.49 77.61 US distribution to CA only. | 1 1.49 79.10 Worldwide Distribution - US (Nationwi.. | 1 1.49 80.60 Worldwide Distribution - US (nationwi.. | 1 1.49 82.09 Worldwide Distribution - US Distribut.. | 1 1.49 83.58 Worldwide Distribution - US Distribut.. | 1 1.49 85.07 Worldwide Distribution - US Nationwid.. | 1 1.49 86.57 Worldwide Distribution -- AE, AO, AR,.. | 1 1.49 88.06 Worldwide Distribution -- US, Belgium.. | 1 1.49 89.55 Worldwide Distribution -- US, includi.. | 1 1.49 91.04 Worldwide Distribution -- US, includi.. | 1 1.49 92.54 Worldwide Distribution -- US, includi.. | 1 1.49 94.03 Worldwide Distribution-US (nationwide.. | 1 1.49 95.52 Worldwide Distribution-US (nationwide.. | 1 1.49 97.01 Worldwide distribution - US (nationwi.. | 1 1.49 98.51 Worldwide distribution to US (state o.. | 1 1.49 100.00 ----------------------------------------+----------------------------------- Total | 67 100.00 Frequencies for recallnumber variable in enfrep20150624 dataset : Recall | Number | Freq. Percent Cum. ------------+----------------------------------- B-0606-15 | 1 1.49 1.49 B-0625-15 | 1 1.49 2.99 B-0652-15 | 1 1.49 4.48 B-0653-15 | 1 1.49 5.97 B-0654-15 | 1 1.49 7.46 B-0655-15 | 1 1.49 8.96 B-0656-15 | 1 1.49 10.45 B-0657-15 | 1 1.49 11.94 B-0658-15 | 1 1.49 13.43 B-0672-15 | 1 1.49 14.93 B-0673-15 | 1 1.49 16.42 B-0674-15 | 1 1.49 17.91 B-0675-15 | 1 1.49 19.40 B-0676-15 | 1 1.49 20.90 B-0690-15 | 1 1.49 22.39 B-0691-15 | 1 1.49 23.88 B-0705-15 | 1 1.49 25.37 B-0706-15 | 1 1.49 26.87 B-0707-15 | 1 1.49 28.36 D-1134-2015 | 1 1.49 29.85 D-1135-2015 | 1 1.49 31.34 D-1136-2015 | 1 1.49 32.84 D-1137-2015 | 1 1.49 34.33 D-1138-2015 | 1 1.49 35.82 D-1139-2015 | 1 1.49 37.31 D-1140-2015 | 1 1.49 38.81 D-1141-2015 | 1 1.49 40.30 D-1142-2015 | 1 1.49 41.79 D-1143-2015 | 1 1.49 43.28 D-1144-2015 | 1 1.49 44.78 D-1145-2015 | 1 1.49 46.27 D-1146-2015 | 1 1.49 47.76 F-2438-2015 | 1 1.49 49.25 F-2439-2015 | 1 1.49 50.75 F-2440-2015 | 1 1.49 52.24 F-2441-2015 | 1 1.49 53.73 F-2442-2015 | 1 1.49 55.22 F-2443-2015 | 1 1.49 56.72 F-2444-2015 | 1 1.49 58.21 F-2731-2015 | 1 1.49 59.70 F-2732-2015 | 1 1.49 61.19 Z-1693-2015 | 1 1.49 62.69 Z-1731-2015 | 1 1.49 64.18 Z-1794-2015 | 1 1.49 65.67 Z-1795-2015 | 1 1.49 67.16 Z-1796-2015 | 1 1.49 68.66 Z-1797-2015 | 1 1.49 70.15 Z-1798-2015 | 1 1.49 71.64 Z-1799-2015 | 1 1.49 73.13 Z-1800-2015 | 1 1.49 74.63 Z-1801-2015 | 1 1.49 76.12 Z-1802-2015 | 1 1.49 77.61 Z-1803-2015 | 1 1.49 79.10 Z-1804-2015 | 1 1.49 80.60 Z-1805-2015 | 1 1.49 82.09 Z-1806-2015 | 1 1.49 83.58 Z-1807-2015 | 1 1.49 85.07 Z-1808-2015 | 1 1.49 86.57 Z-1810-2015 | 1 1.49 88.06 Z-1811-2015 | 1 1.49 89.55 Z-1812-2015 | 1 1.49 91.04 Z-1813-2015 | 1 1.49 92.54 Z-1814-2015 | 1 1.49 94.03 Z-1815-2015 | 1 1.49 95.52 Z-1816-2015 | 1 1.49 97.01 Z-1817-2015 | 1 1.49 98.51 Z-1818-2015 | 1 1.49 100.00 ------------+----------------------------------- Total | 67 100.00 Frequencies for classification variable in enfrep20150624 dataset : Classificat | ion | Freq. Percent Cum. ------------+----------------------------------- Class I | 4 5.97 5.97 Class II | 43 64.18 70.15 Class III | 20 29.85 100.00 ------------+----------------------------------- Total | 67 100.00 Frequencies for productdescription variable in enfrep20150624 dataset : Product Description | Freq. Percent Cum. ----------------------------------------+----------------------------------- 3.7mm Cannulated Locking Screws and 3.. | 1 1.49 1.49 Alaris PC unit model 8015, software v.. | 1 1.49 2.99 Amerigel Hydrogel Gauze Dressing 2 x .. | 1 1.49 4.48 Amlodipine besylate and Atorvastatin .. | 1 1.49 5.97 Amlodipine besylate and Atorvastatin .. | 1 1.49 7.46 Amlodipine besylate and Atorvastatin .. | 1 1.49 8.96 Amlodipine besylate and Atorvastatin .. | 1 1.49 10.45 BD Viper LT System, catalog number 44.. | 1 1.49 11.94 BRAN Whole Foods Market Muffin Bran 6.. | 1 1.49 13.43 BVI Custom Eyes Ophthalmic Procedure .. | 1 1.49 14.93 BVI Custom Eyes Ophthalmic Procedure .. | 1 1.49 16.42 BVI Custom Eyes Ophthalmic Procedure .. | 1 1.49 17.91 BVI Custom Eyes Ophthalmic Procedure .. | 1 1.49 19.40 BVI Custom Eyes Ophthalmic Procedure .. | 1 1.49 20.90 Blood and Blood Products for Reproces.. | 4 5.97 26.87 Brown Peeled and De-veined Shrimp, (U.. | 1 1.49 28.36 Byrds Famous Cookies, Benne Bits, Net.. | 1 1.49 29.85 Byrds Famous Cookies, Vidalia Onion B.. | 1 1.49 31.34 CADD- Solis Ambulatory Infusion Pump,.. | 1 1.49 32.84 CLEARSIGN II Amplifier for LABSYSTEM .. | 1 1.49 34.33 Desiccated Coconut Distributed by: Ph.. | 1 1.49 35.82 Divalproex Sodium Extended-Release Ta.. | 1 1.49 37.31 Divalproex Sodium Extended-Release Ta.. | 1 1.49 38.81 ELI 380 Electrocardiograph. The ELI 3.. | 1 1.49 40.30 Famotidine Tablets, USP, 20 mg Tablet.. | 1 1.49 41.79 Fentanyl Citrate Inj., USP, CII, 250 .. | 1 1.49 43.28 Foradil Aerolizer (formoterol fumarat.. | 1 1.49 44.78 Foradil Aerolizer (formoterol fumarat.. | 1 1.49 46.27 Fresh Driscoll Strawberries, 8 x 16 o.. | 1 1.49 47.76 Garber's Old Fashioned Ice cream, Bir.. | 1 1.49 49.25 Hacizade Pismaniye Pashmak (Cotton Ca.. | 1 1.49 50.75 HeartWare Ventricular Assist System (.. | 1 1.49 52.24 I-Portal NOTC and VNG; a device used .. | 1 1.49 53.73 Integra Camino Intracranial Pressure .. | 1 1.49 55.22 Jose Madrid Salsa Mild NET WT. 13 OZ... | 1 1.49 56.72 Lambda Cell Trays LCTW HLA CLass I .. | 1 1.49 58.21 Lamivudine and Zidovudine Tablets USP.. | 1 1.49 59.70 Loratadine Orally Disintegrating Tabl.. | 1 1.49 61.19 MILEX OMNIFLEX DIAPHRAGM SIZE 80 Mode.. | 1 1.49 62.69 Medtronic Passive Planar Blunt Probe .. | 1 1.49 64.18 NEXIUM (esomeprazole magnesium), Dela.. | 1 1.49 65.67 Navigation System II-Cart, 7700-100-0.. | 1 1.49 67.16 Neusoft NeuViz 64 Multi-slice CT Scan.. | 1 1.49 68.66 Philips Ultrasound, Model Q-Station, .. | 1 1.49 70.15 Plasma Frozen | 1 1.49 71.64 Platelets Pheresis Leukocytes Reduced | 1 1.49 73.13 Pull Reduction Device For 4.3mm Percu.. | 1 1.49 74.63 Red Blood Cells (Apheresis) Leukocyte.. | 3 4.48 79.10 Red Blood Cells (Apheresis) Leukocyte.. | 1 1.49 80.60 Red Blood Cells Leukocytes Reduced | 4 5.97 86.57 Red Blood Cells Leukocytes Reduced Ir.. | 1 1.49 88.06 Source Plasma | 3 4.48 92.54 T.A.L.O.N (Tactically Advanced Lifesa.. | 1 1.49 94.03 T/S2 0.9% Sodium Chloride Injection, .. | 1 1.49 95.52 Thoracic Grasper, 5 MM, for use with .. | 1 1.49 97.01 Vanguard M Unicondylar Tibial Trial .. | 1 1.49 98.51 Viking M, L, and XL Mobile Lifts. N.. | 1 1.49 100.00 ----------------------------------------+----------------------------------- Total | 67 100.00 Frequencies for codeinfo variable in enfrep20150624 dataset : Code Info | Freq. Percent Cum. ----------------------------------------+----------------------------------- Lot # FC0064; Exp. 05/17 | 1 1.49 1.49 #1 lot of 211/ 3 pk produced on 12/12.. | 1 1.49 2.99 *****************US Serial numbers***.. | 1 1.49 4.48 100 count bottle - Lot #C307859, exp .. | 1 1.49 5.97 305000291459, 305000299228, 305000300.. | 1 1.49 7.46 3103376, 3103377, 3103378, 3524557, 3.. | 1 1.49 8.96 601 0101 04/20/16 | 1 1.49 10.45 ALL Lots - 11406, 11414, 12439, 12466.. | 1 1.49 11.94 All product distributed between 08/18.. | 2 2.99 14.93 Best By dates 01/21/15 to 4/6/15 | 1 1.49 16.42 CD0461798 | 1 1.49 17.91 Catalog Identification: LCT1W30, lot .. | 1 1.49 19.40 Catalog number 2002021: lot numbers: .. | 1 1.49 20.90 Code Dates: 0103910512, 0103910513, 0.. | 1 1.49 22.39 Date code 00425 | 1 1.49 23.88 JV0199137; JV0199629; JV0200990; JV02.. | 1 1.49 25.37 JV0228916 | 1 1.49 26.87 KH04090 | 1 1.49 28.36 Lot # C309280 | 1 1.49 29.85 Lot # C402439 | 1 1.49 31.34 Lot #140849 | 1 1.49 32.84 Lot #: 043410, Exp 04/2015; 053391, E.. | 1 1.49 34.33 Lot #: 2625094, Exp 06/2016 | 1 1.49 35.82 Lot #: 3K34915, Expiry: 07/2015 | 1 1.49 37.31 Lot #: F8011, Exp May 2015 | 1 1.49 38.81 Lot #: a) C401536, Exp 07/2015; b) C4.. | 1 1.49 40.30 Lot #: a) C401537, Exp 07/2015; b) C4.. | 1 1.49 41.79 Lot #C308195, exp 10/2015 | 1 1.49 43.28 Lot 14-333 | 1 1.49 44.78 Lot 153309 | 1 1.49 46.27 Lot Numbers: 3038787 3046210 30610.. | 1 1.49 47.76 Lot Numbers: 3039720 3046211 30477.. | 1 1.49 49.25 Lot Numbers: 3045852 3053258 30631.. | 1 1.49 50.75 Lot Numbers: 3068113 3078510 30863.. | 1 1.49 52.24 Lot Numbers: 3035614 3046205 3052693.. | 1 1.49 53.73 Lot#: F0082, Exp May 2015 | 1 1.49 55.22 Model Numbers NOTC-S, NOTC-P, NOTC-C,.. | 1 1.49 56.72 N/A | 1 1.49 58.21 NeuViz 16/64 Series | 1 1.49 59.70 Only the BD Viper LT Systems, catalog.. | 1 1.49 61.19 Part 32-423101 Lot 414930 Part 32-423.. | 1 1.49 62.69 Part Number: 03.120.023, with lot num.. | 1 1.49 64.18 Part Numbers: 02.240.044, 02.240.244,.. | 1 1.49 65.67 Serial #: ALL HeartWare HVAD systems .. | 1 1.49 67.16 Serial Number 114470237158 114470237.. | 1 1.49 68.66 Serial Number US 1061044 1061058 1061.. | 1 1.49 70.15 Serial numbers 100019, 100984, 100965.. | 1 1.49 71.64 Viking M Lift Model 2040035 (S/N 9 2.. | 1 1.49 73.13 W035214023834X, W035214023827V, W0352.. | 1 1.49 74.63 W0352140462178, W0352140470354, W0352.. | 1 1.49 76.12 W036814049540; W036814049540; | 1 1.49 77.61 W036814066774; W036814066774; W036814.. | 1 1.49 79.10 W036815093553 | 1 1.49 80.60 W036815171653 | 1 1.49 82.09 W038514380773 | 2 2.99 85.07 W043215019283 | 1 1.49 86.57 W051514126796 (2 units), W05151409711.. | 1 1.49 88.06 W201114065881-part 1; W201114065881-p.. | 1 1.49 89.55 W201314146870 | 1 1.49 91.04 W202914133548 | 1 1.49 92.54 W204114052068; | 1 1.49 94.03 W398515003667D | 1 1.49 95.52 lot number 150223 | 1 1.49 97.01 software version 9.17 | 1 1.49 98.51 version 420343-01 and 420323-02, all .. | 1 1.49 100.00 ----------------------------------------+----------------------------------- Total | 67 100.00 Frequencies for codeinfocontinued variable in enfrep20150624 dataset : Code Info (Continued) | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 66 98.51 98.51 1064169 1064170 1064171 1064172 1064.. | 1 1.49 100.00 ----------------------------------------+----------------------------------- Total | 67 100.00 Frequencies for productquantity variable in enfrep20150624 dataset : Product Quantity | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 6 8.96 8.96 2427 Distributed. 921 still in house | 1 1.49 10.45 1 unit | 10 14.93 25.37 1,080 units (3 cases) | 1 1.49 26.87 1,718 lbs | 1 1.49 28.36 10 units | 1 1.49 29.85 100 count 7479; 500 count - 2544 | 1 1.49 31.34 1000 X 25 lbs. bags - 25,000 lbs. | 1 1.49 32.84 121 units (30 in US and 91 internatio.. | 1 1.49 34.33 1218 units | 1 1.49 35.82 14,649 Cartons | 1 1.49 37.31 140 | 1 1.49 38.81 156 units | 1 1.49 40.30 176 | 1 1.49 41.79 18 | 1 1.49 43.28 188 (U.S.) and 251 (Foreign) | 1 1.49 44.78 19,658 packs | 1 1.49 46.27 2 units | 2 2.99 49.25 2,074 units | 1 1.49 50.75 2,115 lbs | 1 1.49 52.24 2,436 units | 1 1.49 53.73 200 units | 1 1.49 55.22 214 kits | 1 1.49 56.72 24, 798 | 1 1.49 58.21 25 cases (12 packages per case) | 1 1.49 59.70 2592 Blister Packs | 1 1.49 61.19 268 kits | 1 1.49 62.69 27 | 1 1.49 64.18 3,653 pounds | 1 1.49 65.67 3,747 curently implanted | 1 1.49 67.16 3095 total cases (8 x 1lb or 4 x 2 lb.. | 1 1.49 68.66 34,524 bottles | 1 1.49 70.15 3747 US, 19 Foreign | 1 1.49 71.64 384 kits | 1 1.49 73.13 4 units | 2 2.99 76.12 43 units | 1 1.49 77.61 4426 (2427 US, 1999 OUS) | 1 1.49 79.10 5 installed in US | 1 1.49 80.60 54 | 1 1.49 82.09 55,442 packs | 1 1.49 83.58 585 kits | 1 1.49 85.07 6,491 units | 1 1.49 86.57 621 kits | 1 1.49 88.06 63 units | 1 1.49 89.55 6317 packages | 1 1.49 91.04 7 Viper LT Systems | 1 1.49 92.54 72 | 1 1.49 94.03 8 cs/12/13 oz jars | 1 1.49 95.52 86,106 Cartons | 1 1.49 97.01 9 units | 1 1.49 98.51 925 cartons (30 tablets in each carton) | 1 1.49 100.00 ----------------------------------------+----------------------------------- Total | 67 100.00 Frequencies for reasonforrecall variable in enfrep20150624 dataset : Reason for Recall | Freq. Percent Cum. ----------------------------------------+----------------------------------- A diaphragm size 80 labeled box was i.. | 1 1.49 1.49 A manufacturing error at Hammond Ente.. | 1 1.49 2.99 Blood product, collected from a donor.. | 2 2.99 5.97 Blood product, collected from a donor.. | 1 1.49 7.46 Blood product, collected from a donor.. | 1 1.49 8.96 Blood product, which did not meet acc.. | 1 1.49 10.45 Blood product, which did not meet the.. | 1 1.49 11.94 Blood product, which was collected fr.. | 1 1.49 13.43 Blood products, collected from a dono.. | 1 1.49 14.93 Blood products, collected from a dono.. | 1 1.49 16.42 Blood products, collected from a dono.. | 1 1.49 17.91 Blood products, collected from a dono.. | 2 2.99 20.90 Blood products, which may have reache.. | 2 2.99 23.88 Boston Scientific has received compla.. | 1 1.49 25.37 CGMP Deviations: Failure of the manuf.. | 1 1.49 26.87 CareFusion has identified an issue wi.. | 1 1.49 28.36 Certain affected parts and lots of th.. | 1 1.49 29.85 Certain lots of the 3.7mm Cannulated .. | 1 1.49 31.34 Complaints (including one reported de.. | 1 1.49 32.84 Complaints with the HVAD Internal Con.. | 1 1.49 34.33 Desiccated coconut may be contaminate.. | 1 1.49 35.82 Devon Light Glove in procedure kits m.. | 5 7.46 43.28 Failed Dissolution Specifications; ex.. | 2 2.99 46.27 Failed Impurities/Degradation Specifi.. | 1 1.49 47.76 Failed Stability Specification: out o.. | 2 2.99 50.75 Failed dissolution specifications | 1 1.49 52.24 Firm initiated a recall of certain co.. | 1 1.49 53.73 Firm voluntarily recalling 56 oz. Bir.. | 1 1.49 55.22 Incorrect labeling of the expiration .. | 1 1.49 56.72 Integra LifeSciences is recalling the.. | 1 1.49 58.21 Lambda Cell Trays, with potential hig.. | 1 1.49 59.70 Misbranded red blood cells were distr.. | 2 2.99 62.69 Mortara Instrument, Inc. has recently.. | 1 1.49 64.18 Nonapproved labeling claims (Sterile) | 1 1.49 65.67 Philips Healthcare has discovered a p.. | 1 1.49 67.16 Plasma product, collected from a dono.. | 1 1.49 68.66 Possible glass inclusion. | 1 1.49 70.15 Potential breach in sterility | 1 1.49 71.64 Potential for false positive Chlamydi.. | 1 1.49 73.13 Presence of 16255 - Ponceau 4R (E124).. | 1 1.49 74.63 Presence of Foreign Tablets/Capsules:.. | 1 1.49 76.12 Smiths Medical has become aware of an.. | 1 1.49 77.61 Source plasma product collected from .. | 1 1.49 79.10 Stryker initiated a device recall of .. | 1 1.49 80.60 Subpotent drug | 4 5.97 86.57 Superpotent Drug: Out Of Specificatio.. | 1 1.49 88.06 The A-plane compensator is made of Te.. | 1 1.49 89.55 The Left and Right orientation of the.. | 1 1.49 91.04 The coating of the 5 mm Thoracic Gras.. | 1 1.49 92.54 The firm was informed by the Ohio Dep.. | 1 1.49 94.03 Undeclared Anchovies | 2 2.99 97.01 Undeclared milk and eggs. | 1 1.49 98.51 complaints of system malfunction and .. | 1 1.49 100.00 ----------------------------------------+----------------------------------- Total | 67 100.00 Frequencies for recallinitiationdate variable in enfrep20150624 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 08mar2014 | 1 1.49 1.49 27mar2014 | 2 2.99 4.48 07nov2014 | 1 1.49 5.97 03dec2014 | 1 1.49 7.46 09feb2015 | 3 4.48 11.94 25feb2015 | 1 1.49 13.43 02mar2015 | 1 1.49 14.93 10mar2015 | 1 1.49 16.42 12mar2015 | 2 2.99 19.40 13mar2015 | 1 1.49 20.90 19mar2015 | 3 4.48 25.37 20mar2015 | 1 1.49 26.87 25mar2015 | 1 1.49 28.36 27mar2015 | 1 1.49 29.85 31mar2015 | 1 1.49 31.34 03apr2015 | 1 1.49 32.84 09apr2015 | 2 2.99 35.82 13apr2015 | 1 1.49 37.31 16apr2015 | 1 1.49 38.81 22apr2015 | 1 1.49 40.30 29apr2015 | 1 1.49 41.79 30apr2015 | 1 1.49 43.28 01may2015 | 5 7.46 50.75 04may2015 | 2 2.99 53.73 05may2015 | 1 1.49 55.22 06may2015 | 4 5.97 61.19 12may2015 | 2 2.99 64.18 13may2015 | 3 4.48 68.66 15may2015 | 1 1.49 70.15 18may2015 | 1 1.49 71.64 19may2015 | 1 1.49 73.13 20may2015 | 2 2.99 76.12 21may2015 | 1 1.49 77.61 22may2015 | 4 5.97 83.58 26may2015 | 1 1.49 85.07 27may2015 | 4 5.97 91.04 28may2015 | 3 4.48 95.52 29may2015 | 1 1.49 97.01 02jun2015 | 1 1.49 98.51 10jun2015 | 1 1.49 100.00 ------------+----------------------------------- Total | 67 100.00 Frequencies for recallinitiationdatestr variable in enfrep20150624 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 02/09/2015 | 3 4.48 4.48 02/25/2015 | 1 1.49 5.97 03/02/2015 | 1 1.49 7.46 03/08/2014 | 1 1.49 8.96 03/10/2015 | 1 1.49 10.45 03/12/2015 | 2 2.99 13.43 03/13/2015 | 1 1.49 14.93 03/19/2015 | 3 4.48 19.40 03/20/2015 | 1 1.49 20.90 03/25/2015 | 1 1.49 22.39 03/27/2014 | 2 2.99 25.37 03/27/2015 | 1 1.49 26.87 03/31/2015 | 1 1.49 28.36 04/03/2015 | 1 1.49 29.85 04/09/2015 | 2 2.99 32.84 04/13/2015 | 1 1.49 34.33 04/16/2015 | 1 1.49 35.82 04/22/2015 | 1 1.49 37.31 04/29/2015 | 1 1.49 38.81 04/30/2015 | 1 1.49 40.30 05/01/2015 | 5 7.46 47.76 05/04/2015 | 2 2.99 50.75 05/05/2015 | 1 1.49 52.24 05/06/2015 | 4 5.97 58.21 05/12/2015 | 2 2.99 61.19 05/13/2015 | 3 4.48 65.67 05/15/2015 | 1 1.49 67.16 05/18/2015 | 1 1.49 68.66 05/19/2015 | 1 1.49 70.15 05/20/2015 | 2 2.99 73.13 05/21/2015 | 1 1.49 74.63 05/22/2015 | 4 5.97 80.60 05/26/2015 | 1 1.49 82.09 05/27/2015 | 4 5.97 88.06 05/28/2015 | 3 4.48 92.54 05/29/2015 | 1 1.49 94.03 06/02/2015 | 1 1.49 95.52 06/10/2015 | 1 1.49 97.01 11/07/2014 | 1 1.49 98.51 12/03/2014 | 1 1.49 100.00 ------------+----------------------------------- Total | 67 100.00 Frequencies for reportdate variable in enfrep20150624 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 24jun2015 | 67 100.00 100.00 ------------+----------------------------------- Total | 67 100.00 Frequencies for reportdatestr variable in enfrep20150624 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 06/24/2015 | 67 100.00 100.00 ------------+----------------------------------- Total | 67 100.00 by Jean Roth , jroth@nber.org , 18 Dec 2015