BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEVYN LIFE SACRUM (LARGE) PACK OF 10

    MDR report key: 9241856 · Received October 25, 2019

    Report

    Report Number
    8043484-2019-00750
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    February 17, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED AN EXCESSIVE MOISTURE/MACERATION UNDER THE DRESSINGS AND ADHESIVE WAS PULLING/LIFTING THE SKIN UPON REMOVAL. A SEVEN-LOT NUMBER WAS INVOLVED 201849, 201902, 201908, 201909, 201914, 201918, 201921. IT IS KNOWN WHICH CAUSED MACERATION AND SKIN STRIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034350 ALLEVYN LIFE SACRUM (LARGE) PACK OF 10 TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1