FDA.reportPublic FDA data

MAUDE MDR 980054

MDR report key
980054
Report number
MW5004968
Event key
0
Event type
3
Date received
2008-01-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HOLLISTERDRAINAGE POUCH/BAGHOLLISTERFON70162NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-01-160

Event Narratives#

D

Patient 1

POUCH BROKE AT THE SEAM AFTER 4 HOURS OF USE. IT'S BEEN HAPPENING ONCE A YEAR WITHIN 32 YEARS OF USAGE. EACH TIME, HE HAS RECEIVED A NEW BAG THROUGH MAIL. PATIENT WAS FRUSTRATED BECAUSE OF THIS ONGOING ISSUE.