BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXCARE ABSOLUTE WATERPROOF TAPE

    MDR report key: 3143077 · Received May 24, 2013

    Report

    Report Number
    2110898-2013-00029
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    3M CONSUMER HEALTH CARE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER COMPLAINT DID NOT STATE REASON AS TO WHY FIRST AID WAS APPLIED TO SKIN. IT IS UNK IF THE SKIN WAS COMPROMISED PRIOR TO APPLYING. PRODUCT IS LABELED HYPOALLERGENIC, LATEX FREE MATERIALS, DERMATOLOGIST TESTED. IDEAL FOR WATER RELATED ACTIVITIES - STAYS ON WHEN BATHING OR SWIMMING; EXERCISING -STICKS TO SWEATING SKIN; PREVENTING NEW OR PROTECTING EXISTING BLISTERS; SECURING GAUZE. MFG SITE OF TAPE: 3M (B)(4).

    Description of Event or Problem · 1

    CONSUMER PURCHASED TAPE AND APPLIED IT UNDER LEFT AND RIGHT ARMS (BELOW THE ARM PITS) AND BREAST AREA. AFTER LESS THAN 3 HRS OF WEAR, THE CONSUMER NOTICED WHAT THEY INITIALLY THOUGHT WAS SWEAT UNDER THE TAPE. CONSUMER REMOVED TAPE AND AS THEY DID, THEIR SKIN WAS REMOVED AND PUS STARTED TO COME OUT OF THE DAMAGED SKIN AREAS. SKIN WAS SWOLLEN. CONSUMER WAS IN PAIN AND SOUGHT MEDICAL ATTENTION. THE DOCTOR PRESCRIBED FOUR TYPES OF MEDICATION: KEFLEX, ATARAX, PREDNISONE, AND LORTAB. THEY ALSO APPLIED BACITRACIN ZINC OINTMENT ON THE WOUNDS BEFORE BANDAGING ALL FOUR AREAS UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231299 NEXCARE ABSOLUTE WATERPROOF TAPE 880.5240 MEDICAL ADHESIVE TAPE KGX 3M CONSUMER HEALTH CARE 732 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention