BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER

    MDR report key: 9279989 · Received November 5, 2019

    Report

    Report Number
    1119193-2019-00040
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 23, 2019
    Report Date
    November 5, 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
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN END USER EXPERIENCED PAIN AND BLISTERING UNDER THE TAPE PORTION OF THE OSTOMY BARRIER WITHIN WEEKS OF USE. HE SAW A DERMATOLOGIST WHO PRESCRIBED AN ANTIFUNGAL OINTMENT AND AN ANTIBIOTIC OINTMENT TO USE ON THE AREA FOR 7 DAYS. THE AREA HAS NOW CLEARED UP. END USER WILL TRY HOLLISTER'S TAPELESS BARRIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073148 NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER EXB HOLLISTER INCORPORATED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention