BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW IMAGE FLEXWEAR CUT TO FIT SKIN BARRIER WITHOUT TAPE BORDER

    MDR report key: 9250813 · Received October 29, 2019

    Report

    Report Number
    1119193-2019-00038
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    August 24, 2019
    Report Date
    October 29, 2019
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    EXB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 IS NOT POSSIBLE. SAMPLE NOT RETURNED SO A SAMPLE EVALUATION IS NOT POSSIBLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN END USER EXPERIENCED SEVERE REDNESS AND SKIN BUMPS UNDER THE HOLLISTER OSTOMY BARRIER. NYSTATIN CREAM WAS PRESCRIBED. IT IS HELPING A LITTLE BUT NOT COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045045 NEW IMAGE FLEXWEAR CUT TO FIT SKIN BARRIER WITHOUT TAPE BORDER NEW IMAGE FLEXWEAR CUT TO FIT SKIN BARRIER WITHOUT TAPE BORDER EXB HOLLISTER INCORPORATED 15203 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention