ADAPT BARRIER EXTENDERS
Received Oct 29, 2019 · Event occurred Sep 15, 2019
Report 1064486-2019-00001 · MDR key 9250814
Device
Generic name
Adapt Barrier Extenders
Manufacturer
Hollister IncorporatedCatalog number
79402
Lot number
UNKNOWN
Product problems
- Patient-Device Incompatibility
Patient
5 YR
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH (B)(4) AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW NOT POSSIBLE BECAUSE NOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. THE ROOT CAUSE OF THE RASH IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER DEVELOPED A SKIN RASH UNDER THE PRODUCT AFTER USING THE HOLLISTER BARRIER EXTENDERS FOR 1 WEEK. HE WAS PRESCRIBED SILVADENE CREAM AND IT CLEARED UP IN 2 DAYS.