HOLLISTER NEW IMAGE 2-PIECE OSTOMY SKIN BARRIER
Received Feb 16, 2022 · Event occurred Feb 14, 2022
Report MW5107544 · MDR key 13549602
Device
Generic name
Collector, Ostomy
Manufacturer
Hollister, Inc.Model number
15603Catalog number
15603
Lot number
1C202
Product problems
- Fluid/Blood Leak
- Product Quality Problem
Patient
66 YR · Male
- Exposure to Body Fluids
- Exposure to Body Fluids
Narrative
Description of Event or Problem
HOLLISTER ILEOSTOMY PRODUCT; I HAVE AN ILEOSTOMY, THE RESULT OF SURGERY FOR COLON CANCER. I HAD TO CHANGE THE FLANGE (HOLLISTER MODEL 15603) IN THE MORNING, BUT THE ADHESIVE PORTION OF THE FLANGE BEGAN TO PEEL AWAY FROM MY SKIN THAT EVENING, SO IT STARTED TO LEAK. IN THE END I HAD TO CHANGE THE FLANGE AGAIN: THAT HAS NEVER HAPPENED BEFORE, AND I BELIEVE IT INDICATES A SERIOUS QUALITY PROBLEM WITH HOLLISTER. I HAVE HAD THE ILEOSTOMY FOR 26 YEARS AND IN THAT TIME I HAVE CHANGED THE FLANGE HUNDREDS OF TIMES. NEVER HAVE I EXPERIENCED SUCH A PROBLEM. FDA SAFETY REPORT ID # (B)(4).