BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURAD BASIC CARE PLASTIC

    MDR report key: 827011 · Received March 6, 2007

    Report

    Report Number
    MW1042162
    Event Type
    Injury
    Date Received
    March 6, 2007
    Date of Event
    March 2, 2007
    Report Date
    March 6, 2007
    Manufacturer
    BEIERSDORF, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER A PELVIC MRI, HAD INTENSE CUTANEOUS "RECALL" INFLAMMATION AND TISSUE DAMAGE IN AREAS DIRECTLY UNDERNEATH WHERE CURAD BANDAGES HAD PREVIOUSLY BEEN. NO BANDAGES WERE PRESENT AT THE TIME OF MRI. ARM BANDAID HAD LAST BEEN WORN 24 HOURS PRIOR TO MRI. LEG BANDAID WAS REMOVED 4 DAYS PRIOR TO MRI. AREA INVOLVED ARE WHERE BANDAID ADHESIVE HAD DIRECT CONTACT WITH THE SKIN. ARM TISSUE DAMAGE STARTED 6 HOURS AFTER MRI. LEG DAMAGE STARTED 24 HOURS AFTER MRI. LESIONS INTENSELY ERYTHEMATOUS, EDEMATOUS, PAINFUL, AND ITCHY. SHAPE OF LESIONS ARE IN EXACT SHAPE OF PREVIOUS BANDAIDS. NO MRI CONTRAST WAS USED. BANDAGES ARE CURAD BASIC CARE PLASTIC 3/4 X 2 7/8 INCHES, LOT NUMBER 60639702.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURAD BASIC CARE PLASTIC * KGX BEIERSDORF, INC. * 60639702
    2 CURAD BASIC CARE PLASTIC * KGX BEIERSDORF, INC. * 60639702

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| S