BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAND-AID TRUE STAY SHEER

    MDR report key: 15428434 · Received September 14, 2022

    Report

    Report Number
    MW5112066
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    September 4, 2022
    Report Date
    September 13, 2022
    Manufacturer
    JOHNSON AND JOHNSON CONSUMER INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BAND-AIDE PRODUCT TRUE-STAY SHEER CAUSED BLISTERS ON SKIN WHERE ADHESIVE TOUCHED ON MYSELF AND MY FIANCÉ SKIN AFTER BEING ON SKIN FOR 24 HRS. BAR CODE 8137-004669, LOT #1102B. I DID CONTACT JOHNSON AND JOHNSON AND WAS GIVEN A CASE #(B)(4). I FEEL THAT THIS WARRANTS AN INVESTIGATION INTO THE ADHESIVE THEY ARE USING IN THIS PRODUCT. I HAVE USED BAND-AID PRODUCTS ALL MY LIFE WITHOUT ANY SIDE-EFFECTS SO I AM REPORTING THIS AS A CONCERNED CONSUMER. THANK YOU FOR DOING YOUR PART TO PROTECT THE CITIZENS OF OUR GREAT COUNTRY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2752293 BAND-AID TRUE STAY SHEER TAPE AND BANDAGE, ADHESIVE KGX JOHNSON AND JOHNSON CONSUMER INC. 1102B

    Patients

    Seq Age Sex Outcome Treatment
    1 Female