Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10878029primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received02/03/2015receiptdateformat102Date Last Updated20/05/2015fulfillexpeditecriteria1companynumbUS-ABBVIE-15P-163-1333100-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-15P-163-1333100-00

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age50Unit of Onset AgeyearsWeight130.3SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionEconomic problemOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionLethargyOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionEmotional distressOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionPeripheral swellingOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.0ReactionPalpitationsOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.0ReactionPulmonary embolismOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionSleep disorderOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionInjuryOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionDeep vein thrombosisOutcomeUnknown

10)

reactionmeddraversionpt18.0ReactionPainOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductAMBIEN CRdrugstructuredosagenumb5drugstructuredosageunit003drugdosagetextAT BEDTIMEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774Brand NameAMBIEN CRGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaeespl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76Package NDC0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10UNIIWY6W63843K

2)

drugcharacterization2medicinalproductPROPRANOLOLdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenamePROPRANOLOL\PROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075826Brand NamePROPRANOLOLGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersFresenius Kabi USA, LLCproduct_ndc63323-604Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856443spl_iddb24d808-268b-4bec-bd48-7b66d2bb5951spl_set_idf14ea537-dd5c-4c78-9037-9a85e9e610efPackage NDC63323-604-01UNIIF8A3652H1V

3)

drugcharacterization2medicinalproductMODAFINIL.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameMODAFINIL

openFDA Info on Medication

Application Number ANDA202700, ANDA077667, ANDA202566, NDA020717, ANDA209966, ANDA078963, ANDA20719 ... Brand NameMODAFINIL, PROVIGILGeneric NameMODAFINILManufacturers Alembic Pharmaceuticals Limited, Apotex Corp., Alembic Pharmaceuticals Inc., Ris ... product_ndc 46708-385, 46708-386, 60505-2526, 60505-2527, 62332-385, 62332-386, 57237-154, 5 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMODAFINILRXCUI205324, 260218, 213471, 226426spl_id b7315903-20d7-4dce-80ea-3d33fa5f9f16, a2501635-6969-cca6-92c1-e6259d7d7708, 7aa2 ... spl_set_id 5b8496fe-b647-4ce6-aeef-71245712e46f, 944daf47-49a6-93ca-e348-4a0f1b6d937e, 41f9 ... Package NDC 46708-385-30, 46708-385-91, 46708-385-10, 46708-385-60, 46708-385-90, 46708-386- ... NUIN0000175729, N0000175651, N0000175769Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE], Increased Sympathetic Activity [PE]Established Pharmacologic ClassSympathomimetic-like Agent [EPC]UNIIR3UK8X3U3D

4)

drugcharacterization2medicinalproductDICLOFENAC SOD ECdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

5)

drugcharacterization2medicinalproductPROVIGILdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationSLEEP DISORDERdrugstartdateformat602drugstartdate//2003

activesubstance

activesubstancenameMODAFINIL

openFDA Info on Medication

Application NumberNDA020717Brand NamePROVIGILGeneric NameMODAFINILManufacturersCephalon, Inc.product_ndc63459-101, 63459-201Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMODAFINILRXCUI205324, 213471, 226426, 260218spl_id22321588-2125-4ed0-b9ff-87a8513bf271spl_set_ide16c26ad-7bc2-d155-3a5d-da83ad6492c8Package NDC63459-101-01, 63459-101-30, 63459-201-01, 63459-201-30NUIN0000175729, N0000175651, N0000175769Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE], Increased Sympathetic Activity [PE]Established Pharmacologic ClassSympathomimetic-like Agent [EPC]UNIIR3UK8X3U3D

6)

drugcharacterization2medicinalproductBUPROPION SRdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameBUPROPION

7)

drugcharacterization2medicinalproductENOXAPARINdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameENOXAPARIN

8)

drugcharacterization2medicinalproductWELLBUTRINdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat602drugstartdate//2010

activesubstance

activesubstancenameBUPROPION HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021515, NDA020358Brand NameWELLBUTRIN XL, WELLBUTRIN SRGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLC, GlaxoSmithKline LLCproduct_ndc0187-0730, 0187-0731, 0173-0135, 0173-0947, 0173-0722Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564, 993503, 993511, 993518, 993528, 993536, 993537spl_id63046e0c-233f-4dc1-b3eb-f9d27872bd25, eb423af3-e5f0-4c6c-a698-ff0ef35edcabspl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21, cbc8c074-f080-4489-a5ae-207b5fadeba3Package NDC 0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07, 0173-0947- ... UNIIZG7E5POY8O

9)

drugcharacterization2medicinalproductAMBIENdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaee, c8f05d12-bc35-43cb-8b65-588bec02c73dspl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

10)

drugcharacterization2medicinalproductLOVASTATIN.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameLOVASTATIN

openFDA Info on Medication

Application NumberANDA078296, ANDA075991, NDA021316, ANDA075551, ANDA075636Brand NameLOVASTATIN, ALTOPREVGeneric NameLOVASTATINManufacturers Lupin Pharmaceuticals, Inc., Carlsbad Technology, Inc., Covis Pharma US, Inc, Te ... product_ndc 68180-467, 68180-468, 68180-469, 61442-141, 61442-142, 61442-143, 70515-628, 705 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLOVASTATINRXCUI197903, 197904, 197905, 359731, 359732, 433849, 884383, 997006, 997007spl_id c604f04e-6251-4b55-9cf3-6b534605137b, b18075c3-0ee9-12af-e053-2a95a90a9d89, 6ae2 ... spl_set_id df7ddf4f-d569-431e-81f1-9129d7043150, 0a680e13-0356-4e08-a7fe-78b96ba51b9d, 8c0d ... Package NDC 68180-467-09, 68180-467-07, 68180-467-01, 68180-467-03, 68180-467-05, 68180-468- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNII9LHU78OQFD

11)

drugcharacterization2medicinalproductPRISTIQ EXTENDED RELEASEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDESVENLAFAXINE SUCCINATE

12)

drugcharacterization2medicinalproductWARFARIN SODIUM.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameWARFARIN SODIUM

openFDA Info on Medication

Application NumberANDA040663, ANDA040301, ANDA090935, ANDA040416, ANDA040616, ANDA202202Brand NameWARFARIN SODIUM, JANTOVENGeneric NameWARFARIN SODIUM, WARFARINManufacturers Cadila Healthcare Limited, Taro Pharmaceuticals U.S.A., Inc., Exelan Pharmaceuti ... product_ndc 65841-052, 65841-053, 65841-064, 65841-054, 65841-055, 65841-056, 65841-057, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI 855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344, 855292, ... spl_id b9846c53-80c7-4264-a78f-87c3b18edfc7, 23995412-b23d-4ea0-96df-f1b31ce4f024, 45e8 ... spl_set_id 3fb2aa58-3a40-4255-a261-e2db5b9a5dde, 8ad881e0-ca41-42ad-9d7d-eb85b3a30af0, c0cc ... Package NDC 65841-052-01, 65841-052-10, 65841-053-01, 65841-053-10, 65841-064-01, 65841-064- ... UNII6153CWM0CL

13)

drugcharacterization2medicinalproductBUPROPION HCLdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameBUPROPION HYDROCHLORIDE

14)

drugcharacterization2medicinalproductAMPHETAMINE SALTSdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancename AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMP ...

15)

drugcharacterization2medicinalproductLUNESTAdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

16)

drugcharacterization2medicinalproductVIIBRYDdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameVILAZODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022567Brand NameVIIBRYDGeneric NameVILAZODONE HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc0456-1100, 0456-1110, 0456-1120, 0456-1140, 0456-1101Product TypeHUMAN PRESCRIPTION DRUGRouteORALRXCUI 1086772, 1086776, 1086778, 1086780, 1086784, 1086786, 1086789, 1086790, 1653469, ... spl_id64357f87-0563-474e-909d-44ab85452cd4spl_set_id4c55ccfb-c4cf-11df-851a-0800200c9a66Package NDC0456-1110-30, 0456-1120-30, 0456-1140-30, 0456-1100-31, 0456-1101-30UNIIU8HTX2GK8JActive IngredientsVILAZODONE HYDROCHLORIDE

17)

drugcharacterization2medicinalproductINVEGA VIIBRYDdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat602drugstartdate//2010

18)

drugcharacterization2medicinalproductINVEGAdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenamePALIPERIDONE

openFDA Info on Medication

Application NumberNDA021999Brand NameINVEGAGeneric NamePALIPERIDONEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-550, 50458-551, 50458-552, 50458-554Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPALIPERIDONERXCUI672567, 672569, 672571, 686441, 686443, 686445, 866103, 866105spl_id7afcf6c3-c5b6-4600-a1ec-3869f66a1c98spl_set_id7b8e5b26-b9e4-4704-921b-3c3c0d159916Package NDC 50458-550-01, 50458-550-10, 50458-550-98, 50458-551-01, 50458-551-10, 50458-551- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII838F01T721

19)

drugcharacterization2medicinalproductTRAZODONEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

20)

drugcharacterization2medicinalproductHYDROCODONE-ACETAMINPHENdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

21)

drugcharacterization1medicinalproductANDROGELdrugbatchnumbUNKNOWNdrugauthorizationnumb021015drugadministrationroute061drugindicationBLOOD TESTOSTERONE DECREASEDdrugenddateformat610drugenddate/03/2013actiondrug1

activesubstance

activesubstancenameTESTOSTERONE

openFDA Info on Medication

Application NumberNDA022309, NDA021015Brand NameANDROGELGeneric NameTESTOSTERONEManufacturersAbbVie Inc.product_ndc0051-8462, 0051-8425, 0051-8488, 0051-8450Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMALActive IngredientsTESTOSTERONERXCUI 1597075, 1597076, 1597120, 1597121, 1597126, 1597127, 1596780, 1597074, 1597123, ... spl_idd34e7ee8-3f6b-4473-8e1b-f3a90467fb6c, 2e54dd8d-cf81-4c69-ad15-fa24f47dd3daspl_set_id8677ba5b-8374-46cb-854c-403972e9ddf3, c506aaa3-04f8-4eb1-8dc4-e964cdd08e7fPackage NDC 0051-8462-33, 0051-8462-12, 0051-8462-31, 0051-8462-01, 0051-8462-30, 0051-8488- ... NUIN0000175824, N0000000146, M0001109Established Pharmacologic ClassAndrogen [EPC]Mechanism of ActionAndrogen Receptor Agonists [MoA]Chemical StructureAndrostanes [CS]UNII3XMK78S47O

22)

drugcharacterization2medicinalproductWARFARINdrugindicationANTICOAGULANT THERAPYdrugstartdateformat602drugstartdate//2009

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, 02a5640e-a453-4463-976c-34d448423071spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

23)

drugcharacterization2medicinalproductCLONAZAPAMdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

24)

drugcharacterization2medicinalproductAMOXICILLIN.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameAMOXICILLIN

openFDA Info on Medication

Application Number ANDA065255, ANDA065056, ANDA065271, ANDA065256, ANDA064013, ANDA061926, ANDA0619 ... Brand NameAMOXICILLINGeneric NameAMOXICILLINManufacturers Hikma Pharmaceuticals USA Inc., Teva Pharmaceuticals USA, Inc., NorthStar Rx LLC ... product_ndc 0143-9285, 0093-2263, 0093-2264, 16714-298, 16714-299, 57237-028, 57237-029, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMOXICILLINRXCUI308194, 308192, 308182, 308191, 239191, 308177, 598025, 308189, 313850, 313797spl_id 11f42795-cdea-4c98-a921-2c54e40370ba, 7b44bb9c-2d87-4260-81f1-fea8539749a5, 832f ... spl_set_id c8591c2a-92ef-4432-b19a-bb46063047ee, 20c86622-85b7-4827-a317-57aee79dfe57, 843f ... Package NDC 0143-9285-01, 0143-9285-20, 0093-2263-01, 0093-2264-01, 16714-298-01, 16714-298- ... UNII804826J2HU

25)

drugcharacterization2medicinalproductOXYCODONE-ACETAMINOPHENdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameACETAMINOPHEN\OXYCODONE HYDROCHLORIDE

26)

drugcharacterization2medicinalproductGABAPENTIN.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 59afc809-201f-4cf8-95f6-67ae52c0a327, 4553 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

27)

drugcharacterization2medicinalproductCYCLOBENZAPRINEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameCYCLOBENZAPRINE

openFDA Info on Medication

Application NumberANDA090478, ANDA071611Brand NameCYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINEGeneric NameCYCLOBENZAPRINE, CYCLOBENZAPRINE HYDROCHLORIDEManufacturersCipla USA Inc., Rising Health, LLCproduct_ndc69097-845, 69097-846, 57237-266Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCYCLOBENZAPRINE HYDROCHLORIDERXCUI828320, 828348, 828299spl_id0e5c376d-9599-4825-9226-016d40cf6113, 09330886-13f8-44cc-98d2-883f3e0514b4spl_set_id575a31fb-04c5-4001-88a7-c33adbacc6a8, b12fb4ea-182e-462b-b6ed-cfd2f6bb71e8Package NDC69097-845-07, 69097-845-15, 69097-846-07, 69097-846-15, 57237-266-01UNII0VE05JYS2P

summary

narrativeincludeclinicalCASE EVENT DATE: 200907