FDA.reportPublic FDA data

MAUDE MDR 2081824

MDR report key
2081824
Report number
MW5020505
Event key
0
Event type
3
Date of event
2010-07-30
Date received
2011-05-03
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
1ADAPTPASTEHOLLISTER INCORPORATED CONSUMER PROGRAMS TEAMSEZR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-05-0301. O

Event Narratives#

D

Patient 1

I HAVE AN OSTOMY BAG WHICH I HAVE WORN FOR APPROXIMATELY 18 YEARS. IN THE (B)(6) 2010, I STARTED TO GET RED DOTS ON MY SKIN WHICH I ATTRIBUTED TO THE HEAT. AS TIME WENT ON, THE SKIN GOT REDDER AND THE TISSUE BEGAN TO SEEP FLUID TO THE POINT IN 2011, I COULD NOT WEAR THE BAG DUE TO EXCESSIVE SEEPING. I CONTACTED MY OSTOMY NURSE WHO TRIED DIFFERENT PRODUCTS TO THE POINT SHE WAS AT A LOSS. AT THAT POINT, I WENT TO A SURGEON WHO INITIALLY THOUGHT IT WAS MY CROHN'S ATTACKING MY SKIN. HE PUT ME ON A DOSE OF PREDNISONE AND THAT HELPED THE SKIN START TO CLEAR. ONCE I TAPERED OF THE PREDNISONE, THE WEEPING SKIN AND ULCERATIONS STARTED UP AGAIN. HE THEN PUT ME ON A LONG REGIMEN OF PREDNISONE AND HAD ME SLOWLY TAPER AND NOTIFY HIM IF THE SKIN STARTED TO GET WORSE. AT 30MG OF PREDNISONE, THE SKIN STARTED TO REDDEN AND WEEP AGAIN. HE THEN SAID, I NEEDED TO SEE A DERMATOLOGIST. DATES OF USE: (B)(6) 1990 - (B)(6) 2011.