BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 540875 · Received August 25, 2004

    Report

    Report Number
    2528909-2004-00020
    Event Type
    Other
    Date Received
    August 25, 2004
    Date of Event
    July 16, 2004
    Report Date
    August 24, 2004
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT WAS TREATED WITH FREEZE OFF, WART LOCATED ON FOREARM BELOW WRIST (DESCRIBED AS 1" LONG). APPLICATION OF 20 SECONDS CAUSED PAIN AND WAS DISCONTINUED. CUSTOMER WAS SEEN BY DOCTOR WHO REMOVED LOOSE SKIN AFTER BLISTER BROKE. DOCTOR PRESCRIBED BURN CREAM (TWICE A DAY). FAMILY REPORTED THAT PT HAS INSUFFICIENT FEELING IN ARM (UNABLE TO DISTINGUISH BETWEEN EXTREME HEAT AND WARM, EXTREME COLD AND COOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUND W FREEZE OFF CRYOSURGICAL WART TREATMENT SYSTEM GEH ORASURE TECHNOLOGIES, INC. * 5727

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other