BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODERMA FLEX UROSTOMY POUCH WITH CONVEX SKIN BARRIER

    MDR report key: 7042267 · Received November 17, 2017

    Report

    Report Number
    1119193-2017-00036
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    May 8, 2017
    Report Date
    November 17, 2017
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    EXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822255 MODERMA FLEX UROSTOMY POUCH WITH CONVEX SKIN BARRIER UROSTOMY POUCH EXG HOLLISTER INCORPORATED 2969139

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention