BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANDAIDS, FIRST AID WRAPS, STERI-STRIPS, FIRST AID PACKAGING

    MDR report key: 2123034 · Received April 13, 2011

    Report

    Report Number
    MW5020951
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 1, 2001
    Report Date
    April 13, 2011
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOUND THAT THE MOST COMMON BANDAGE/FIRST AID SUPPLY MANUFACTURER - (B)(6) BRAND, HAD NO CLEARLY LABELED PRODUCTS THAT WERE APPROPRIATE FOR INDIVIDUALS WITH A LATEX ALLERGY. THIS HAS BEEN AN ONGOING FINDING FOR TEN YEARS. AS A LATEX ALLERGIC INDIVIDUAL, ONE OF MANY IN ONE OF THE FASTEST GROWING SENSITIVITIES IN THE WORLD, ACCESSING SAFE FIRST AID SUPPLIES IS ESSENTIAL. LATEX SENSITIVITY IS CUMULATIVE, MEANING EACH EXPOSURE FURTHER SENSITIZES AN INDIVIDUAL AND CAN LEAD TO A COMPLETE INTOLERANCE OF LATEX. THAT RESPONSE IS KNOWN AS ANAPHYLAXIS AND IT IS LIFE THREATENING. HOW HORRIFIC WOULD IT BE FOR THE LARGEST SUPPLIER TO BE TARGETED BY LAWSUITS BECAUSE IT WAS THE LAST TO JUMP ON THE SAFETY WAGON. IN A TIME WHEN MORE AND MORE AREAS ARE EXPECTED TO COMPLY BY ADA REGULATIONS AND ACCOMMODATE A MULTITUDE OF FOOD AND ENVIRONMENTAL ALLERGENS - HOW LONG MUST WE WAIT FOR THE COMPANY WITH THE MOST VARIETY AND HIGH QUALITY ITEMS TO PRESENT SAFE PRODUCTS TO THE PUBLIC. A NOTE TO THE CUSTOMER SERVICE DEPARTMENT IS BEING WRITTEN AND SENT TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BANDAIDS, FIRST AID WRAPS, STERI-STRIPS, FIRST AID PACKAGING BANDAIDS, FIRST AID WRAPS, STERI-STRIPS, FIRST AID PACKAGING KGX JOHNSON & JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR