NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER
Received Jan 28, 2020 · Event occurred Jan 1, 2020
Report 1119193-2020-00003 · MDR key 9637935
Device
Generic name
New Image Convex Flextend Skin Barrier With Tape Border
Manufacturer
Hollister IncroporatedCatalog number
14910
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
50 YR
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
LOT NUMBER NOT PROVIDED SO DHR REVIEW IS NOT POSSIBLE. SAMPLE NOT RETURNED SO A SAMPLE EVALUATION IS NOT POSSIBLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. END USER STATES THAT THE DEVICE DID NOT MALFUNCTION. THE PRODUCT DID NOT FIT WELL WITH HIS PARTICULAR STOMA SHAPE AND WHEN HE SWITCHED TO A PRODUCT THAT BETTER FIT HIM, THE REPORTED ISSUE WENT AWAY. END USER'S WEIGHT ESTIMATED BECAUSE ACTUAL INFORMATION IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED URINE LEAKAGE UNDER THE HOLLISTER OSTOMY APPLIANCE DUE A HERNIA CAUSING HIS STOMA TO TAKE ON AN ODD SHAPE. THE LEAKAGE LED TO SKIN IRRITATION AND SKIN INFECTION. THE END USER WAS PRESCRIBED ORAL ANTIBIOTICS FOR 1 WEEK AND THE SKIN INFECTION CLEARED UP. HE HAS SINCE CHANGED TO A DIFFERENT HOLLISTER APPLIANCE AND IS NO LONGER EXPERIENCING THE ISSUE.