BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 534137 · Received July 12, 2004

    Report

    Report Number
    2528909-2004-00011
    Event Type
    Injury
    Date Received
    July 12, 2004
    Date of Event
    June 4, 2004
    Report Date
    July 12, 2004
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER TREATED WART LOCATED ON INSIDE OF RIGHT LEG THIGH. CUSTOMER REPORTS THAT THEY FOLLOWED THE DIRECTIONS BUT WITHIN ONE SECOND OF TOUCHING APPLICATOR TO THE WART IT STARTED TO HISS AND FREEZING DRIPPED DOWN THEIR LEG. THE NEXT MORNING THEY HAD 4 OR 5 LARGE BLISTERS IN THE AREA. CUSTOMER SOUGHT MEDICAL ATTENTION (DOCTOR'S NAME/INFORMATION UNKNOWN). CUSTOMER HAS RETAINED A LAWYER AND CO HAS NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUND W FREEZE OFF CRYOSURGICAL WART TREATMENT SYSTEM GEH ORASURE TECHNOLOGIES, INC. * 5826

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other