NEW IMAGE TWO-PIECE POUCHING SYSTEM
Received Apr 23, 2019 · Event occurred Apr 1, 2019
Report 1119193-2019-00013 · MDR key 8540445
Device
Generic name
New Image Flexwear Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
14203
Lot number
8K082
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
63 YR
- Skin Erosion
- Skin Erosion
Narrative
Additional Manufacturer Narrative
NO SAMPLE RECEIVED SO A DEVICE EXAMINATION NOT POSSIBLE. LOT NUMBER PROVIDED. DEVICE HISTORY RECORD REVIEW CONDUCTED AND NO ISSUES IDENTIFIED. THE ROOT CAUSE OF THE REPORTED SKIN ISSUE CANNOT BE IDENTIFIED. 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 THE END USER EXPERIENCED BLISTERS, WEEPING SKIN AND SORES AROUND THE STOMA AFTER USING THE 14203 SKIN BARRIER. STOOL THEN STARTED UNDERMINING HIS BARRIER CAUSING SKIN IRRITATION. HE WAS SEEN IN THE ER AND ANTIBIOTICS GIVEN. THE SKIN HAS IMPROVED BUT SORES ARE STARTING AGAIN.