BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIER

    MDR report key: 20213288 · Received September 13, 2024

    Report

    Report Number
    9616668-2024-00005
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    September 11, 2024
    Report Date
    September 13, 2024
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    EXG
    UDI-DI
    00610075064496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A LOT NUMBER WAS NOT PROVIDED SO THE DEVICE HISTORY RECORDS WERE NOT ABLE TO BE REVIEWED. NO SAMPLES WERE AVAILABLE FOR RETURN SO DEVICE EXAMINATION NOT POSSIBLE. COMPLAINT DATA REVIEW WAS CONDUCTED, AND NO ADVERSE TRENDS OBSERVED. THE ROOT CAUSE OF THE REPORTED SKIN IRRITATION COULD NOT BE DETERMINED. CAUSATION HAS NOT BEEN ESTABLISHED. SINCE A LOT NUMBER WAS NOT PROVIDED, ONLY GUDID DI INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN END USER HAS BEEN EXPERIENCING IRRITATED SKIN UNDER THE HOLLISTER OSTOMY BARRIER SINCE MARCH OF THIS YEAR. IT WAS REPORTED THAT THE PERISTOMAL SKIN IS ITCHY, RED AND BUMPY. IT WAS FURTHER REPORTED THAT THE IRRITATED SKIN CONTINUED DESPITE USING DIFFERENT TYPES OF OSTOMY BARRIERS OVER A PERIOD OF TIME. IT WAS FURTHER REPORTED THAT HE WAS PRESCRIBED CLOBETASOL PROPIONATE CREAM TO BE USED ON HIS IRRITATED SKIN UNDER THE APPLIANCE FOR TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666755 PREMIER 1-PIECE UROSTOMY POUCH, SOFT CONVEX, CERAPLUS EXG HOLLISTER INCORPORATED 8414 UNKNOWN 00610075064496

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention