BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WART DEVICE

    MDR report key: 1232258 · Received November 14, 2008

    Report

    Report Number
    MW5008993
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 10, 2008
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USED OTC "WART FREEZE" DEVICE AND SUSTAINED A 3RD DEGREE BURN ON HIS ARM, (DEVICE WITHOUT CAPABILITY OF ADJUSTING WIDTH TO TREAT AFFECTED AREA ONLY). DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: WARTS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WART DEVICE GEH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other