Adverse Event Report

Report

Version of Safety Report ID4Safety Report ID11793407primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate29/08/2017reporttype1serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received02/12/2015receiptdateformat102Date Last Updated24/06/2017fulfillexpeditecriteria1companynumbUS-ENDO PHARMACEUTICALS INC.-2015-004396duplicate1

Report Duplicate

duplicatesourceENDOduplicatenumbUS-ENDO PHARMACEUTICALS INC.-2015-004396

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age55Unit of Onset AgeyearsWeight111.11SexMale

Reaction

1)

reactionmeddraversionpt20.0ReactionOedema peripheralOutcomeRecovered/resolved

2)

reactionmeddraversionpt20.0ReactionTherapeutic response unexpectedOutcomeUnknown

3)

reactionmeddraversionpt20.0ReactionPain in extremityOutcomeRecovered/resolved

4)

reactionmeddraversionpt20.0ReactionIntentional product misuseOutcomeUnknown

5)

reactionmeddraversionpt20.0ReactionWeight increasedOutcomeRecovered/resolved

6)

reactionmeddraversionpt20.0ReactionAbdominal distensionOutcomeRecovered/resolved

7)

reactionmeddraversionpt20.0ReactionPainOutcomeRecovered/resolved

8)

reactionmeddraversionpt20.0ReactionDrug dose omissionOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductOPANA ERdrugbatchnumbUNKdrugauthorizationnumb021610drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationPAINdrugstartdateformat610drugstartdate/11/2010drugenddateformat602drugenddate//2013actiondrug3

activesubstance

activesubstancenameOXYMORPHONE HYDROCHLORIDE

2)

drugcharacterization1medicinalproductOPANA ERdrugbatchnumbUNKdrugauthorizationnumb021610drugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat610drugstartdate/03/2013actiondrug3

activesubstance

activesubstancenameOXYMORPHONE HYDROCHLORIDE

3)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2011

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

4)

drugcharacterization2medicinalproductPERCOCETdrugdosagetextUNK UNK, UNKNOWNdrugdosageformTABLETdrugindicationPAINdrugstartdateformat602drugstartdate//2006

activesubstance

activesubstancenameACETAMINOPHEN\OXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, OXYCODONE HYDROCHLORIDERXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNIIC1ENJ2TE6C, 362O9ITL9D

summary

narrativeincludeclinicalCASE EVENT DATE: 2013