BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 493622 · Received October 31, 2003

    Report

    Report Number
    2528909-2003-00001
    Event Type
    Other
    Date Received
    October 31, 2003
    Date of Event
    September 29, 2003
    Report Date
    October 30, 2003
    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

    FAMILY MEMBER APPLIED COMPOUND W FREEZE OFF TO PATIENT'S LEG TO TREAT A WART. LEG WENT STIFF AND BURNED. PURCHASED PRODUCT 2003, USED FIRST TIME 5 DAYS LATER IN THE EVENING. WART IS IN CREASE BEHIND KNEE AND BURN IS ONE INCH ACROSS CREASE. FAMILY MEMBER STATES THEY USED PER DIRECTION, HOWEVER COULD STILL HEAR HISSING SOUND, ALTHOUGH NOT PASSING APPLICATOR WHILE IN CONTACT WITH SKIN. STOPPED APPLICATION WITH PATIENT'S CRIES. FAMILY MEMBER CLAIMS THAT APPLICATION LEFT ONE INCH BURN AND SAYS THE LEG WAS FROZEN AS WELL, LEFT MARK AND STILL HURTS TO MOVE LEG. NO MEDICAL ATTENTION SOUGHT AT THE TIME OF APPLICATION/INJURY. DOCTOR CONSULTED 3 DAYS AFTER APPLICATION, DIAGNOSIS SECOND 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 8 YR Required Intervention