BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 517584 · Received March 23, 2004

    Report

    Report Number
    2528909-2004-00003
    Event Type
    Other
    Date Received
    March 23, 2004
    Date of Event
    February 23, 2004
    Report Date
    March 23, 2004
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT USED FREEZE OFF ONCE ON THEIR MIDDLE FINGER. THE FINGER BECAME SWOLLEN AND LOOKED LIKE IT HAD A CHEMICAL BURN. PT WAS TAKEN TO DR TO SEEK MEDICAL TREATMENT DUE TO INTENSE PAIN. THE PT HAS NO KNOWN ALLERGIES OR MEDICAL CONDITIONS. CUSTOMER INDICATED THAT THE PRODUCT WAS USED FOR 45 SECONDS AND DONE IN ACCORDANCE WITH DIRECTIONS. THE DR GAVE THE PT PAIN KILLER, WRAPPED THE AREA, CLEANED IT, AND SAID THAT IT WAS A CHEMICAL BURN. THE AREA WAS ALL BUBBLED UP LIKE A BLISTER (WHICH IS AN EXPECTED REACTION). THE WART WAS ON THE INSIDE OF THEIR FINGER, AND THE WHOLE FINGER, ON THE OPPOSITE SIDE OF WHERE THE WART WAS TREATED IS PURPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUND W FREEZE OFF WART REMOVAL SYSTEM GEH ORASURE TECHNOLOGIES, INC. * 0503

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other