Adverse Event Report

Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10015742serious1Date Last Updated04/04/2016receiptdateformat102companynumbUS-BAYER-2014-039404occurcountryUSseriousnessother1duplicate1Date Received17/03/2014transmissiondate15/08/2016primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age22Unit of Onset Ageyearspatientagegroup5Weight56.69SexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionInfertility femaleOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt19.0ReactionMaternal exposure before pregnancy

3)

reactionmeddraversionpt19.0ReactionUterine perforation

4)

reactionmeddraversionpt19.0ReactionAbortion spontaneous

5)

reactionmeddraversionpt19.0ReactionInjury

6)

reactionmeddraversionpt19.0ReactionDevice issue

7)

reactionmeddraversionpt19.0ReactionPain

8)

reactionmeddraversionpt19.0ReactionAbdominal pain lower

Drug

1)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNKdrugindicationPOSTPARTUM DEPRESSIONdrugstartdateformat602drugstartdate//2009

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

2)

drugcharacterization1medicinalproductMIRENAdrugauthorizationnumb021225drugstructuredosagenumb20drugstructuredosageunit004drugdosagetext20 MCG/24HR, CONTdrugdosageformINTRAUTERINE DELIVERY SYSTEMdrugadministrationroute015drugindicationCONTRACEPTIONdrugstartdateformat102drugstartdate03/04/2009drugenddateformat102drugenddate03/03/2012actiondrug1

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

summary

narrativeincludeclinicalCASE EVENT DATE: 201202

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-039404

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use