PREMIER CONVEX TAPE BORDERED UROSTOMY POUCH WITH 1-1/2" PRE-SIZED OPENING 84898

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-23 for PREMIER CONVEX TAPE BORDERED UROSTOMY POUCH WITH 1-1/2" PRE-SIZED OPENING 84898 manufactured by Hollister Incorporated.

MAUDE Entry Details

Report Number1119193-2019-00031
MDR Report Key8817210
Date Received2019-07-23
Date of Report2019-07-23
Date of Event2019-07-12
Date Mfgr Received2019-07-19
Date Added to Maude2019-07-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDA WISOWATY
Manufacturer Street2000 HOLLISTER DRIVE
Manufacturer CityLIBERTYVILLE. 600483781
Manufacturer CountryUS
Manufacturer Postal600483781
Manufacturer Phone8476802170
Manufacturer G1HOLLISTER INCORPORATED
Manufacturer Street366 DRAFT AVENUE
Manufacturer CitySTUARTS DRAFT VA 244779998
Manufacturer CountryUS
Manufacturer Postal Code244779998
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePREMIER CONVEX TAPE BORDERED UROSTOMY POUCH WITH 1-1/2" PRE-SIZED OPENING
Generic NamePREMIER CONVEX TAPE BORDERED UROSTOMY POUCH WITH 1-1/2" PRE-SIZED OPENING
Product CodeEXB
Date Received2019-07-23
Catalog Number84898
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLLISTER INCORPORATED
Manufacturer Address2000 HOLLISTER DRIVE LIBERTYVILLE IL 600483781 US 600483781


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-23

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