BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM BANDAGE

    MDR report key: 1317517 · Received February 15, 2009

    Report

    Report Number
    MW5009994
    Event Type
    Injury
    Date Received
    February 15, 2009
    Date of Event
    February 7, 2009
    Report Date
    February 15, 2009
    Manufacturer
    3 M
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS HOSPITALIZED FOR BOUT OF SHINGLES. NURSES USED TEGADERM BANDAGING AT THE IV SITE. I IMMEDIATELY NOTICED 3 HUGE BLISTERS UNDER THE TEGADERM. NURSE REMOVED THE IV AND STARTED NEW LINE - AGAIN USING TEGADERM. WITHIN MINUTES, I NOTICED MORE BLISTERING AND REDNESS. AGAIN SHE REMOVED IV SITE AND STARTED NEW LINE IN MY FOREARM - AGAIN USING TEGADERM - AGAINST MY REQUEST NOT TO USE THOSE BANDAGES. I HAVE ALREADY MADE MY COMPLAINT TO THE HOSPITAL - WITHIN MINUTES, I HAD DEVELOPED MANY LARGE RED BLISTERS UNDER THE TEGADERM. CONSEQUENTLY, I DEVELOPED A VERY SEVERE INFECTION THAT THEY CALLED CELLULITIS AND AFTER 5 DIFFERENT TYPES OF ANTIBIOTICS AND ANOTHER WEEK IN THE HOSPITAL - I AM LEFT TO PERFORM IV INFUSIONS ON MYSELF FOR ANOTHER 2 WEEKS AND WILL HAVE A VERY LARGE SCAR AS A RESULT OF TEGADERM. I WILL ALSO REQUIRE A PLASTIC SURGEON FOR A POSSIBLE SKIN GRAFT. I HAVE RESEARCHED WEB BLOGS AND FIND THAT MANY OTHERS HAVE HAD THE SAME REACTION. I HAVE SENT A LETTER TO 3M - BUT WOULD LIKE TO KNOW IF THERE ARE ANY OTHER DOCUMENTED ALLERGIC REACTIONS TO TEGADERM AND IF SO, WHY DOESN'T THE PUBLIC KNOW ABOUT THE POSSIBILITY OF THIS SEVERE REACTION? ALSO - I TOOK PICTURES USING MY CAMERA PHONE OF THE BLISTERED SITES. TEGADERM BANDAGES WERE USED WHILE HOSPITALIZED AT THE HOSPITAL. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: IV SITE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEGADERM BANDAGE UNK NAD 3 M

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R