MalfunctionEXB
PREMIER SOFTFLEX
Received Aug 5, 2019 · Event occurred Feb 22, 2019
Report 8859954 · MDR key 8859954
Device
Generic name
Collector, Ostomy
Manufacturer
Hollister IncorporatedModel number
82500Catalog number
82500
Lot number
242261
Product problems
- Loss of or Failure to Bond
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
MULTIPLE UROSTOMY BAGS (PREMIER ONE-PIECE UROSTOMY POUCH-FLAT EXTEND BARRIER, TAPE) FOUND TO HAVE ADHESIVE THAT DOES NOT STICK.