BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW IMAGE FLEXTEND TAPE BORDERED BARRIER 2-1/4" FLG 1-3/4" PRESIZED OPENING

    MDR report key: 9341071 · Received November 19, 2019

    Report

    Report Number
    1119193-2019-00041
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    September 3, 2019
    Report Date
    November 19, 2019
    Manufacturer
    HOLLISTER INCROPORATED
    Product Code
    EXB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. SAMPLES NOT AVAILABLE SO REVIEW NOT POSSIBLE. END USER'S WEIGHT NOT AVAILABLE SO AN ESTIMATION WAS USED IN THIS REPORT. THE ROOT CAUSE OF THE REPORTED SKIN IRRITATION CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN END USER EXPERIENCED A RASH WITH SMALL AREAS OF SORES, BLISTERS AND BLEEDING UNDER THE BARRIER PORTION OF THE OSTOMY APPLIANCE. THE END USER WAS PRESCRIBED TOPICAL STEROIDS, HYDROGEL AND A DRESSING FOR THE AREA. THE END USER'S WOCN STATED THERE WAS NOTHING WRONG WITH THE OSTOMY BARRIER AND THAT HER SKIN IS JUST SENSITIVE. THE AREAS ARE NOW HEALING IN RESPONSE TO THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134863 NEW IMAGE FLEXTEND TAPE BORDERED BARRIER 2-1/4" FLG 1-3/4" PRESIZED OPENING NEW IMAGE FLEXTEND TAPE BORDERED BARRIER 2-1/4" FLG 1-3/4" PRESIZED OPENING EXB HOLLISTER INCROPORATED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention