NEW IMAGE FLEXTEND PRE SIZED BARRIER
Received Feb 16, 2021 · Event occurred Jan 22, 2021
Report 1119193-2021-00009 · MDR key 11333193
Device
Generic name
New Image Flextend Pre Sized Barrier
Manufacturer
Hollister IncorporatedCatalog number
14703
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
88 YR
- Rash
- Blister
- Rash
- Blister
Narrative
Additional Manufacturer Narrative
THE LOT NUMBER IS NOT KNOWN SO THE DEVICE HISTORY RECORD REVIEW IS NOT POSSIBLE. THE DEVICE NOT SAVED FOR RETURN SO DEVICE EVALUATION NOT POSSIBLE. THE TREND ANALYSIS CONDUCTED SHOWED NO ADVERSE TRENDS FOR SKIN IRRITATION. THE ROOT CAUSE OF THE SKIN IRRITATION IS NOT KNOWN. IN ADDITION, IT IS NOT KNOWN IF THE HOLLISTER BARRIERS CAUSED OR CONTRIBUTED TO THIS REPORTED ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER WHO HAD BEEN USING HOLLISTER OSTOMY BARRIERS FOR OVER A YEAR, RECENTLY DEVELOPED BLISTERS OF VARIOUS SIZES UNDER THE BARRIER AND TAPE. HE HAS BEEN TO MANY HEALTHCARE PROVIDERS WHO CANNOT DETERMINE THE CAUSE OF THE IRRITATION. A DERMATOLOGIST RECENTLY TOOK A BIOPSY OF THE BLISTER TO BE EXAMINED FOR BULLOUS PEMPHIGOID. ABOUT 3 WEEKS AGO, HE WAS PRESCRIBED TRIAMCINOLONE ACETONIDE CREAM TO USE ON THE IRRITATED SKIN. HOLLISTER WILL SEND OUT A DIFFERENT BARRIER PRODUCT FOR HIM TO SAMPLE.