BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER 1" PS

    MDR report key: 8752436 · Received July 2, 2019

    Report

    Report Number
    1119193-2019-00028
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    June 18, 2019
    Report Date
    July 2, 2019
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    EXB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT END USER DEVELOPED AN ERYTHEMATOUS RED RASH UNDER THE TAPE BORDER OF THE OSTOMY BARRIER. THE END USER WAS PRESCRIBED KENALOG SPRAY TO TREAT THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549388 NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER 1" PS NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER EXB HOLLISTER INCORPORATED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention