NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER - CUT TO FIT
Received Jul 9, 2019 · Event occurred Jul 5, 2019
Report 1119193-2019-00029 · MDR key 8771976
Device
Generic name
New Image Flextend Skin Barrier With Tape Border - Cut To Fit
Manufacturer
Hollister IncorporatedCatalog number
14604
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
63 YR
- Erythema
- Erythema
Narrative
Additional Manufacturer Narrative
NO SAMPLE RECEIVED AND NO LOT NUMBER PROVIDED. WITHOUT THE SAMPLE OR LOT NUMBER HOLLISTER IS UNABLE TO PERFORM A FULL INVESTIGATION REGARDING THE SKIN ISSUE. THIS WILL CONTINUE TO BE MONITORED IN HOLLISTER'S POST MARKETED COMPLAINT SYSTEM AND ACTIONS WILL BE TAKEN IF/WHEN INDICATED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER DEVELOPED RED AND RAW SKIN UNDER THE OSTOMY BARRIER. REDNESS STARTED WHEN HE WAS DISCHARGED FROM THE HOSPITAL ON JUNE 22. ON JULY 5TH HE WENT TO THE ER FOR TREATMENT. THEY PRESCRIBED NYSTATIN POWDER. TODAY, THREE DAYS LATER, THE AREA IS ALREADY IMPROVING.