NEW IMAGE TWO-PIECE POUCHING SYSTEM
Received Aug 13, 2019 · Event occurred May 17, 2019
Report 1119193-2019-00035 · MDR key 8888582
Device
Generic name
New Image Flextend Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
14603
Lot number
UNKNOWN
Product problems
- Inadequacy of Device Shape and/or Size
- Inadequate User Interface
Patient
75 YR
- Laceration(s)
- Laceration(s)
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 EVENT. TREND ANALYSIS CONDUCTED AND NO NEGATIVE TRENDS OBSERVED. END USER STATED THAT SHE DID NOT KNOW THAT SHE WAS CUTTING HER BARRIER OPENING TOO SMALL CAUSING IT TO CUT INTO HER STOMA.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER'S STOMA WAS BLEEDING AND SHE COULDN'T FIGURE OUT WHY. SHE WENT TO THE ER WHERE THE BLEEDING AREA WAS CAUTERIZED. SHE LATER FOUND OUT THAT THE OSTOMY BARRIER EDGES THAT SHE WAS CUTTING TO FIT HER STOMA, WAS BEING CUT TOO SMALL, CAUSING IT TO RUB AGAINST AND CUT HER STOMA CAUSING IT TO BLEED. SHE HAS SINCE CUT THE BARRIER OPENING BIGGER AND IT IS NO LONGER CUTTING HER STOMA.