MODERMA FLEX UROSTOMY POUCH WITH CONVEX SKIN BARRIER
Received Nov 17, 2017 · Event occurred May 8, 2017
Report 1119193-2017-00036 · MDR key 7042267
Device
Generic name
Urostomy Pouch
Manufacturer
Hollister IncorporatedModel number
2969139Catalog number
2969139
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
64 YR
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Additional Manufacturer Narrative
A DEVICE MALFUNCTION HAS NOT BEEN ALLEGED OR DETERMINED. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 16TH FROM THE CLINICAL NURSE WHO CARED FOR THE PATIENT. THE OPINION OF THE TREATING NURSE IS THAT THE PRESENCE OF CONVEXITY AGAINST THE PATIENT'S PERISTOMAL SKIN CAUSED THE PRESSURE AREA. THE USE OF CONVEXITY FOR PATIENTS WITH FLUSH OR RECEDING STOMAS IS THE STANDARD PRACTICE; HOWEVER, THE POTENTIAL EXISTS FOR PRESSURE-RELATED ISSUES THAT SHOULD BE MONITORED DURING ITS USE TO DETERMINE IF THE BENEFITS OF USING THE PRODUCT OUTWEIGH THE RISK OF EFFLUENT LEAKAGE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2017 WITH A STAGE 2 PRESSURE INJURY NEAR HIS URINARY STOMA WHICH WAS ATTRIBUTED TO THE HOLLISTER CONVEX UROSTOMY POUCH. THE PATIENT WAS TREATED THROUGH (B)(6) 2017 WITH OVER 42 VISITS TO THE CLINIC. THE PRESSURE ULCER HAS HEALED. IT WAS NOTED BY THE CLINIC THAT THE PATIENT DID HAVE A WEIGHT GAIN WHICH IS BELIEVED TO HAVE CONTRIBUTED TO THE PRESSURE ULCER OCCURRING.