BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW IMAGE TWO-PIECE POUCHING SYSTEM

    MDR report key: 9401991 · Received December 3, 2019

    Report

    Report Number
    1119193-2019-00043
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    November 18, 2019
    Report Date
    December 3, 2019
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    EXB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW NOT POSSIBLE BECAUSE LOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. THE ROOT CAUSE OF THE REPORTED BLISTERS UNDER THE SKIN BARRIER CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER EXPERIENCED OPEN BLISTERS, EXTENDING BEYOND THE EDGES OF THE BARRIER AFTER USING 7917 SKIN GEL PROTECTIVE WIPES ALONG WITH THIS 14203 BARRIER. THE END USER WAS TREATED WITH ORAL PREDNISONE, NYSTATIN POWDER AND NEOSPORIN. END USER WILL BE SENT SAMPLES OF ANOTHER BARRIER PRODUCT TO TRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198918 NEW IMAGE TWO-PIECE POUCHING SYSTEM NEW IMAGE FLEXWEAR SKIN BARRIER WITH TAPE BORDER EXB HOLLISTER INCORPORATED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention