FDA.reportPublic FDA data

MAUDE MDR 8227514

MDR report key
8227514
Report number
1119193-2019-00001
Event key
0
Event type
3
Date of event
2018-12-20
Date received
2019-01-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LINDA WISOWATY
Address
2000 HOLLISTER DRIVE LIBERTYVILLE. 60048 US
Phone
847-847-8476
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADAPT FLAT BARRIER RINGADAPT FLAT BARRIER RINGS 2"HOLLISTER INCORPORATEDEXB78058K022R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-0801. R

Event Narratives#

N

Patient 1

NO SAMPLE RECEIVED. DHR REVIEW CONDUCTED AND NO ISSUES FOUND. THE ROOT CAUSE OF THE END USER'S REPORTED YEAST INFECTION CANNOT BE DETERMINED. THIS WILL CONTINUE TO BE MONITORED IN HOLLISTER'S POST MARKETED COMPLAINT SYSTEM AND ACTIONS WILL BE TAKEN IF/WHEN INDICATED.

D

Patient 1

IT WAS REPORTED THAT THE END USER DEVELOPED REDNESS UNDER HIS UROSTOMY BARRIER RING WHICH EXTENDING DOWN TOWARD HIS GROIN. THIS STARTED ABOUT 2 WEEKS AGO AND THERE WAS NO PAIN OR ITCHING. HE WENT TO THE DOCTOR WHO DIAGNOSED IT AS A YEAST INFECTION AND PRESCRIBED NYSTOP. HOLLISTER WILL BE PROVIDING A DIFFERENT BARRIER RING FORMULATION FOR END USER TO TRY.