BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 497618 · Received November 24, 2003

    Report

    Report Number
    2528909-2003-00004
    Event Type
    Other
    Date Received
    November 24, 2003
    Date of Event
    November 7, 2003
    Report Date
    November 24, 2003
    Manufacturer
    ORASURE TECHNOLOGIES, INC
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT TREATED FOR WART IN CENTER OF HAND (IT IS UNKNOWN WHO APPLIED TREATMENT). FAMILY MEMBER DESCRIBES INCIDENT AS: "AS SOON AS APPLICATOR TOUCHED WART, LIQUID STARTED TO SPREAD UP PT'S ARM UNTIL ANOTHER FAMILY MEMBER STOPPED FLOW. SPREAD ABOUT SIX INCHES DOWN THE ARM. IT WAS BURNING AT THE TIME (FROZEN) SKIN TURNED BLUISH GRAY AND VERY COLD TO THE TOUCH." MEDICAL ATTENTION WAS SOUGHT. REPORTS THIRD DEGREE BURN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention