BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEVYN LIFE M 12.9X12.9 CTN10

    MDR report key: 9241403 · Received October 25, 2019

    Report

    Report Number
    8043484-2019-00745
    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 THAT THE ADHESIVE WAS PULLING/LIFTING THE SKIN UPON REMOVAL, SKIN-STRIPPING WAS CONFIRMED IN ELDERLY PATIENTS WITH THIN FRAGILE SKIN; NO COMMON COMORBIDITIES. SIX LOT NUMBERS WERE INVOLVED: 201834, 201851, 201907, 201910, 201911, 201915. IT IS UNKNOWN WHICH CAUSED THE SKIN STRIPPED AND HOW MANY PATIENTS WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032648 ALLEVYN LIFE M 12.9X12.9 CTN10 TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1