ADAPT FLAT BARRIER RING
Received Dec 6, 2018 · Event occurred Nov 13, 2018
Report 1119193-2018-00045 · MDR key 8137291
Device
Generic name
Adapt Flat Barrier Rings 2"
Manufacturer
Hollister IncorporatedCatalog number
7805
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
70 YR
- Impaired Healing
- Impaired Healing
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 END USER USED A PIECE OF PRODUCT TO COVER AN OPEN CUT FOR 36 HOURS ON HER THUMB. DAYS LATER, A CALLOUS FORMED IN THE AREA OF THE CUT WITH A DARK CENTER. THE DERMATOLOGIST THINKS THE PRODUCT IRRITATED THE SKIN AND CAUSED A REACTION. THE DERMATOLOGIST SCRAPED THE LESION AND SENT IT TO THE LAB FOR CULTURE.