SUR-FIT NATURA 2 PC POST OP UROSTOMY POUCH 416948

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-05 for SUR-FIT NATURA 2 PC POST OP UROSTOMY POUCH 416948 manufactured by Convatec, Inc..

Event Text Entries

[15126642] The wound ostomy care nurse reported that the tape collar on the wafer will not stick within 1-2 days of wear when used on post operative urostomy patients. The tape collar lifts and migrates creating the wafer to leak. The collar lifts from either the top or close to the midline incision.
Patient Sequence No: 1, Text Type: D, B5


[15431101] Based on the available info, this event is deemed to be a reportable malfunction. No add'l pt/event details have been provided to date. Should add'l info become available, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1049092-2014-00601
MDR Report Key4324821
Report Source05
Date Received2014-12-05
Date of Report2014-11-05
Date Mfgr Received2014-11-05
Device Manufacturer Date2014-07-01
Date Added to Maude2014-12-17
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 FDA0
Event Location0
Manufacturer ContactMATTHEW WALENCIAK, ASSOC. DIRECTO
Manufacturer Street211 AMERICAN AVE.
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone9083779293
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUR-FIT NATURA 2 PC POST OP UROSTOMY POUCH
Generic NameBAG, DRAINAGE, WITH ADHESIVE, OSTOMY
Product CodeFON
Date Received2014-12-05
Model Number416948
Lot Number4G02585
Device Expiration Date2019-07-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC, INC.
Manufacturer Address211 AMERICAN AVE. GREENSBORO NC 27409 US 27409


Patients

Patient NumberTreatmentOutcomeDate
10 2014-12-05

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