BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM TRANSPARENT DRESSING

    MDR report key: 2140504 · Received June 21, 2011

    Report

    Report Number
    MW5021098
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    September 13, 2010
    Report Date
    June 21, 2011
    Manufacturer
    3M
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SEVERE ALLERGIC REACTION TO TEGADERM BANDAGE. TEGADERM WAS USED ON ME IN (B)(6) 2009 WHEN I HAD A RIGHT HEART CATHETERIZATION AND I EXPERIENCED HIVES AND WAS PRESCRIBED PREDNISONE. I WAS TOLD AT THAT TIME TO NOTIFY THE DOCTORS AND NURSES THAT I AM ALLERGIC TO TEGADERM. ON (B)(6) 2010, I HAD MINOR SURGERY AND HAD INFORMED THE HOSPITAL I WAS ALLERGIC TO TEGADERM. THEY USED IT ANYWAY AND I HAD 3 OPEN SORES ON MY CHEST WHERE THE TAPE WAS IN ADDITION TO HIVES AND DIFFICULTY BREATHING. I WAS PRESCRIBED PREDNISONE AND BENADRYL AND IT CALMED DOWN. IN (B)(6) 2011, I HAD MAJOR SURGERY AND NOTIFIED THE HOSPITAL THAT I WAS ALLERGIC TO TEGADERM BUT THAT OPSITE IS OKAY ON MY SKIN. THE HOSPITAL ONLY CARRIED TEGADERM AND ENDED UP USING PAPER TAPE ON MY IV SITES. I AM IMMUNOCOMPROMISED DUE TO MEDICATIONS I TAKE FOR A NEUROMUSCULAR DISORDER AND THIS PUT ME AT GREAT RISK IN THE HOSPITAL SETTING. DATES OF USE: 3 HOURS (B)(6) 2009, 2 HOURS (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEGADERM TRANSPARENT DRESSING TRANSPARENT FILM DRESSING KGX 3M

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other