Adverse Event Report

Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10013733serious1Date Last Updated25/02/2015receiptdateformat102companynumbUS-BAYER-2014-038701occurcountryUSduplicate1Date Received16/03/2014seriousnesshospitalization1transmissiondate20/07/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age24Unit of Onset Ageyearspatientagegroup5Weight68.27SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionMedical device discomfort

2)

reactionmeddraversionpt18.0ReactionDevice dislocation

3)

reactionmeddraversionpt18.0ReactionPain

4)

reactionmeddraversionpt18.0ReactionDevice difficult to use

5)

reactionmeddraversionpt18.0ReactionDevice defective

6)

reactionmeddraversionpt18.0ReactionAbdominal pain

7)

reactionmeddraversionpt18.0ReactionUterine perforation

8)

reactionmeddraversionpt18.0ReactionInjury

Drug

1)

drugcharacterization2medicinalproductIBUPROFEN.

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

2)

drugcharacterization2medicinalproductDEPO-PROVERA

activesubstance

activesubstancenameMEDROXYPROGESTERONE ACETATE

openFDA Info on Medication

Application NumberNDA020246Brand NameDEPO-PROVERAGeneric NameMEDROXYPROGESTERONE ACETATEManufacturersPharmacia & Upjohn Company LLCproduct_ndc0009-0746, 0009-7376Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARActive IngredientsMEDROXYPROGESTERONE ACETATERXCUI1000126, 1000128, 1000153, 1000154spl_id8088c906-ead8-4afb-965a-599ff3ae1919spl_set_id199cf13e-0859-4a73-9b45-e700d0cd1049Package NDC0009-0746-30, 0009-0746-35, 0009-7376-11UNIIC2QI4IOI2G

3)

drugcharacterization1medicinalproductMIRENAdrugbatchnumbTU00564drugauthorizationnumb021225drugstructuredosagenumb20drugstructuredosageunit004drugdosagetext20 MCG/24HR, CONTdrugdosageformINTRAUTERINE DELIVERY SYSTEMdrugadministrationroute015drugindicationCONTRACEPTIONdrugstartdateformat102drugstartdate28/05/2010drugenddateformat102drugenddate09/07/2010actiondrug1

activesubstance

activesubstancenameLEVONORGESTREL

openFDA Info on Medication

Application NumberNDA021225Brand NameMIRENAGeneric NameLEVONORGESTRELManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-423Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAUTERINEActive IngredientsLEVONORGESTRELRXCUI804156, 807283spl_id66f86bba-49cd-4a8a-9769-605ccb9f94f7spl_set_iddcbd6aa2-b3fa-479a-a676-56ea742962fcPackage NDC50419-423-01, 50419-423-08NUIN0000175830, M0447349, N0000175602, N0000175832Physiologic/Pharmacodynamic EffectInhibit Ovum Fertilization [PE]Chemical StructureProgesterone Congeners [CS]Established Pharmacologic ClassProgestin [EPC], Progestin-containing Intrauterine Device [EPC]UNII5W7SIA7YZW

4)

drugcharacterization2medicinalproductZOLOFT

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

summary

narrativeincludeclinicalCASE EVENT DATE: 201005

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-038701

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use