BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER - CUT TO FIT

    MDR report key: 9375062 · Received November 26, 2019

    Report

    Report Number
    1119193-2019-00042
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    November 11, 2019
    Report Date
    November 26, 2019
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    EXB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. DHR REVIEWED AND FOUND TO BE COMPLETE AND ACCURATE. ACTUAL END USER WEIGHT IS NOT KNOWN SO AN ESTIMATE WAS USED. IN VIVO SKIN SENSITIZATION TESTING IS PERFORMED TO IDENTIFY THE POTENTIAL RISK OF AN ALLERGIC RESPONSE. SOME INDIVIDUALS MAY STILL BE SENSITIVE TO A SPECIFIC MATERIAL THAT HAS MET ALL SENSITIZATION TEST REQUIREMENTS AND THE SEVERITY OF THEIR RESPONSE CANNOT BE PREDICTED. ROOT CAUSE OF THIS REPORTED ISSUE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN END USER EXPERIENCED A REACTION UNDER THE TAPE AND BARRIER PORTION OF THE OSTOMY APPLIANCE. THIS REACTION, OVER TIME, SPREAD TO HER WHOLE BODY. HER DOCTOR PRESCRIBED TOPICAL STEROIDS AND ORAL ANTIHISTAMINES. SHE WAS ALSO TREATED FOR A YEAST INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171189 NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER - CUT TO FIT NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER - CUT TO FIT EXB HOLLISTER INCORPORATED 8K132

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention