Adverse Event Report

Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10056498serious1Date Last Updated16/06/2014receiptdateformat102seriousnessdeath1companynumbADR-2014-00510seriousnessother1duplicate1Date Received01/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age62Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDevice failure

2)

reactionmeddraversionpt17.0ReactionUrinary retention

3)

reactionmeddraversionpt17.0ReactionHaemorrhage

4)

reactionmeddraversionpt17.0ReactionAbdominal distension

5)

reactionmeddraversionpt17.0ReactionCardio-respiratory arrest

6)

reactionmeddraversionpt17.0ReactionPost procedural complication

7)

reactionmeddraversionpt17.0ReactionNo therapeutic response

8)

reactionmeddraversionpt17.0ReactionDevice breakage

9)

reactionmeddraversionpt17.0ReactionGastric dilatation

10)

reactionmeddraversionpt17.0ReactionPost procedural haemorrhage

11)

reactionmeddraversionpt17.0ReactionConstipation

Drug

1)

drugcharacterization1medicinalproductLIORESAL INTRATHECALdrugauthorizationnumb020075drugindicationMUSCLE SPASTICITY

2)

drugcharacterization1medicinalproductUNSPECIFIED

3)

drugcharacterization1medicinalproductPROVENTIL INHALER

4)

drugcharacterization1medicinalproductASPIRIN

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

5)

drugcharacterization1medicinalproductCOLACE

openFDA Info on Medication

Application Numberpart334Brand NameCOLACEGeneric NameDOCUSATE SODIUM, DOCUSATE SODIUM - SENNOSIDESManufacturersAvrio Health L.P.product_ndc67618-101, 67618-110, 67618-111Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDOCUSATE SODIUM, SENNOSIDESRXCUI1115005, 1247756, 998740, 1872920, 1247759, 1247761spl_id 008f0cb3-8a9a-42f6-b985-a3dbc0deabc0, 7ec009a7-4793-524b-5e6d-202f324d81fd, f8b2 ... spl_set_id 7793fced-e8ee-44e2-b212-dd2a59a5f462, 9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b, a159 ... Package NDC 67618-101-10, 67618-101-30, 67618-101-60, 67618-101-52, 67618-110-10, 67618-110- ... UNIIF05Q2T2JA0, 3FYP5M0IJX

6)

drugcharacterization1medicinalproductFERROUS SULFATE

openFDA Info on Medication

Brand NameFERROUS SULFATE, FERRUM SULPHURICUMGeneric NameFERROUS SULFATE, IRON SUPPLEMENT THERAPYManufacturers Richmond Pharmaceuticals, Inc., Boiron, Healthlife of USA, Washington Homeopathi ... product_ndc54738-963, 0220-2111, 69517-133, 68428-941, 71919-293Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFERROUS SULFATERXCUI310325spl_id 9a63ba0a-0ded-744b-e053-2a95a90a9344, 8723d1f8-ed45-3373-e053-2991aa0a81d7, 655e ... spl_set_id 58dd4f30-980b-44bc-9f8e-8d4626854b91, 7a4087d8-d054-bbdc-e053-2991aa0ae8cf, 3810 ... Package NDC 54738-963-01, 54738-963-03, 0220-2111-41, 69517-133-30, 68428-941-03, 68428-941- ... UNII39R4TAN1VT

7)

drugcharacterization1medicinalproductADVAIR

openFDA Info on Medication

Application NumberNDA021077Brand NameADVAIR DISKUSGeneric NameFLUTICASONE PROPIONATE AND SALMETEROLManufacturersGlaxoSmithKline LLCproduct_ndc0173-0695, 0173-0696, 0173-0697Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsSALMETEROL XINAFOATE, FLUTICASONE PROPIONATERXCUI 896161, 896165, 896184, 896185, 896186, 896190, 896209, 896212, 896218, 896222, ... spl_idc03442a4-17dc-4c49-ae07-3f8f7f26e0dfspl_set_id4eeb5f6a-593f-4a9e-9692-adefa2caf8fcPackage NDC 0173-0695-00, 0173-0695-04, 0173-0696-00, 0173-0696-04, 0173-0697-00, 0173-0697- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

8)

drugcharacterization1medicinalproductFOLIC ACID

openFDA Info on Medication

Application Number ANDA040796, ANDA204418, ANDA202437, ANDA091145, ANDA211064, ANDA202522, ANDA0407 ... Brand NameFOLIC ACID, VENEXA, VITREXYL, VITREXATE, VITRANOLGeneric NameFOLIC ACIDManufacturers Leading Pharma, LLC, Marlex Pharmaceuticals Inc, PureTek Corporation, Cadila Pha ... product_ndc 69315-127, 10135-182, 59088-176, 71209-007, 58657-150, 11534-165, 58657-151, 731 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients FOLIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, MAGNESIUM OXIDE, CHROMIUM NICOTINAT ... RXCUI310410, 237786spl_id 92322e52-3179-4738-8c8a-14fef62311d4, ba726c8a-bfad-11f7-e053-2995a90a239e, ba13 ... spl_set_id 1ba8c407-9613-4319-ac40-0a429cb0f3f4, 35cd5498-0af8-4bcc-a755-bf30f37b091a, ba13 ... Package NDC 69315-127-01, 69315-127-10, 10135-182-01, 10135-182-10, 59088-176-54, 71209-007- ... UNII 935E97BOY8, WR1WPI7EW8, 3A3U0GI71G, A150AY412V, 68Y4CF58BV, 81AH48963U, H6241UJ2 ... NUIM0022797, N0000175952, N0000193618, M0001797, M0022794, N0000175951Chemical StructureVitamin D [CS], Ascorbic Acid [CS], Vitamin B 12 [CS]Established Pharmacologic ClassVitamin D [EPC], Vitamin C [EPC], Vitamin B12 [EPC]

9)

drugcharacterization1medicinalproductGABAPENTIN

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, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... 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

10)

drugcharacterization1medicinalproductHYDROCODONE

11)

drugcharacterization1medicinalproductHYDRALAZINE

openFDA Info on Medication

Application NumberANDA203845Brand NameHYDRALAZINEGeneric NameHYDRALAZINE HYDROCHLORIDEManufacturersNivagen Pharmaceuticals, Inc.product_ndc75834-126, 75834-127, 75834-128Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDRALAZINE HYDROCHLORIDERXCUI905222, 905225, 905395spl_id7bb9db08-2d7a-476a-a1c2-a2b2834c632fspl_set_id1fd8cf42-66ae-4af5-a5ae-7c9679a0e532Package NDC 75834-126-01, 75834-126-00, 75834-127-01, 75834-127-00, 75834-128-01, 75834-128- ... UNIIFD171B778Y

12)

drugcharacterization1medicinalproductLEVIMIR

13)

drugcharacterization1medicinalproductGLUCOPHAGE

openFDA Info on Medication

Application NumberNDA021202Brand NameGLUCOPHAGE XRGeneric NameMETFORMIN HYDROCHLORIDEManufacturersBristol-Myers Squibb Companyproduct_ndc0087-6063, 0087-6060, 0087-6070, 0087-6071, 0087-6064Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI860975, 860977, 860981, 860983, 861004, 861006, 861007, 861008, 861010, 861012spl_id390c09cf-cc7c-4684-8d7c-d9709a5484faspl_set_id4a0166c7-7097-4e4a-9036-6c9a60d08fc6Package NDC 0087-6060-05, 0087-6060-10, 0087-6070-05, 0087-6071-11, 0087-6063-13, 0087-6064- ... UNII786Z46389E

14)

drugcharacterization1medicinalproductPRILOSEC

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharmaproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_id1bd73b0f-b2c2-4409-94ce-1955c6ab119bspl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

15)

drugcharacterization1medicinalproductMIRALAX

openFDA Info on Medication

Application NumberNDA022015Brand NameMIRALAXGeneric NamePOLYETHYLENE GLYCOL 3350ManufacturersBayer HealthCare LLC.product_ndc11523-4357, 11523-7268, 11523-7234, 11523-7341Product TypeHUMAN OTC DRUGRouteORALActive IngredientsPOLYETHYLENE GLYCOL 3350RXCUI876193, 876195spl_idb1cc7dea-6153-4b82-e053-2995a90a62a7spl_set_idd69ce3d4-7ca4-4fe3-b49e-6655e48d6963Package NDC 11523-7268-3, 11523-7268-8, 11523-7268-7, 11523-7268-4, 11523-7268-9, 11523-7234 ... NUIN0000010288, N0000175811, N0000009871Mechanism of ActionOsmotic Activity [MoA]Established Pharmacologic ClassOsmotic Laxative [EPC]Physiologic/Pharmacodynamic EffectStimulation Large Intestine Fluid/Electrolyte Secretion [PE]UNIIG2M7P15E5P

16)

drugcharacterization1medicinalproductPHENERGAN

openFDA Info on Medication

Application NumberANDA083312Brand NamePHENERGANGeneric NamePROMETHAZINE HYDROCHLORIDEManufacturersWest-Ward Pharmaceuticals Corp.product_ndc0641-6082, 0641-6083, 0641-6084, 0641-6085Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992460, 992462, 992858, 992876spl_ided9c544d-8e03-45cb-8509-b71b630d764d, 30c98ca9-a937-425d-9890-949edadd312cspl_set_id6f7e47cc-f823-4336-8107-f980e3049617, 481866da-a712-48a5-853f-8e84aacaab6dPackage NDC 0641-6082-01, 0641-6082-25, 0641-6083-01, 0641-6083-25, 0641-6084-01, 0641-6084- ... UNIIR61ZEH7I1I

17)

drugcharacterization1medicinalproductZOLOFT

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

18)

drugcharacterization1medicinalproductZOCOR

openFDA Info on Medication

Application NumberNDA019766Brand NameZOCORGeneric NameSIMVASTATINManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0543, 0006-0749, 0006-0740, 0006-0735Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI104490, 104491, 152923, 198211, 200345, 213319, 312961, 314231spl_id41a60de3-6740-43c7-a8d7-7dbfd0a8d6a0spl_set_idfdbfe194-b845-42c5-bb87-a48118bc72e7Package NDC 0006-0543-31, 0006-0543-54, 0006-0749-31, 0006-0749-54, 0006-0740-54, 0006-0740- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

19)

drugcharacterization1medicinalproductDIOVAN

openFDA Info on Medication

Application NumberNDA021283Brand NameDIOVANGeneric NameVALSARTANManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0358, 0078-0423, 0078-0359, 0078-0360Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVALSARTANRXCUI349199, 349200, 349201, 349483, 351761, 351762, 352001, 352274spl_id48f59b36-64c2-46ef-827a-b9ed53df270fspl_set_id5ddba454-f3e6-43c2-a7a6-58365d297213Package NDC0078-0423-15, 0078-0358-34, 0078-0359-34, 0078-0360-34NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNII80M03YXJ7I

Report Duplicate

duplicatesourceMEDTRONICduplicatenumbADR-2014-00510

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use