BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RITE-AID

    MDR report key: 1726975 · Received June 9, 2010

    Report

    Report Number
    MW5016387
    Event Type
    Injury
    Date Received
    June 9, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 9, 2010
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LABELING PROBLEM WITH SELF-ADHESIVE OTC BANDAGES. I AM ALLERGIC TO CERTAIN TYPES OF ADHESIVE SOMETIMES USED ON OTC BANDAGES LIKE BANDAIDS AND SIMILAR BY OTHER MANUFACTURERS. APPARENTLY, THERE IS NO LABELING REQUIREMENT FOR THESE PRODUCTS THAT INCLUDES THE TYPES OF ADHESIVE USED. A "NOT FOR USE ON SENSITIVE SKIN" WARNING IS NOT SUFFICIENT. PLEASE CONSIDER ESTABLISHING LABELING REQUIREMENTS FOR SELF-ADHESIVE BANDAGES THAT INCLUDES THE ADHESIVE USED. FYI: MY ALLERGY HAS NOTHING TO DO WITH LATEX - ONLY THE ADHESIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITE-AID LARGE BANDAGE KGX

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other