BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 467074 · Received June 16, 2003

    Report

    Report Number
    MW1028723
    Event Type
    Other
    Date Received
    June 16, 2003
    Date of Event
    May 9, 2003
    Report Date
    June 16, 2003
    Manufacturer
    *
    Product Code
    ELZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DENTIST INSTALLED TEMPORARY ACRYLIC CROWN. EXPERIENCED RASH 4 DAYS LATER. RASH LED TO HIVES AND SWELLING. RESULTING IN CHEMICALLY BURNT SKIN. LAYER OF SKIN ON HANDS, ARMS, AND FEET PEELED OFF. PRIMARY CARE DR DIDN'T KNOW WHAT IT WAS, GAVE PT STEROIDS. CLEARED UP AND CAME BACK TWICE AS BAD. ALLERGIST NEVER SAW ANYTHING LIKE IT, ASSUMED IT WAS ALLERGIC REACTION TO MEDICINES -DIURETIC AND TRAZODONE-. RETURNED TO DENTIST 6/2003 AND SHOWED HIM. HE SAID HE HIGHLY SUSPECTED REACTION TO TEMPORARY ACRYLIC CROWN. HE REMOVED TEMPORARY CROWN THAT DAY AND REPLACED WITH PERMANENT ONE. IMPROVEMENT IN CONDITION BEGAN IMMEDIATELY. STILL HAVE SKIN PEELING AND BOWELS ARE STILL REMOVING TOXINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ACRYLIC CROWN MATERIALS ELZ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other