BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 517605 · Received March 23, 2004

    Report

    Report Number
    2528909-2004-00002
    Event Type
    Other
    Date Received
    March 23, 2004
    Date of Event
    October 30, 2003
    Report Date
    March 23, 2004
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER HAD PURCHASED FREEZE OFF AND FIRST APPLIED IT AT ABOUT 4PM, AND BY 9:30PM THE SAME DAY HAD TO GO TO THE E.R. BASED ON FAMILY MEMBER'S RECOMMENDATION. CUSTOMER APPLIED THE APPLICATOR STRAIGHT TO THE WARTS AND SPRAYED. WARTS (36 OF THEM) WERE ON THEIR ANKLE, KNEES, LEGS AND HANDS. THEY DID NOT KNOW HOW LONG THEY KEPT THE APPLICATOR ON THE AREA. THEY RETREATED THE SAME AREA WITHIN AN HOUR OF THEIR FIRST APPLICATION. AT THE E.R. CUSTOMER WAS TOLD THEY HAD 2ND DEGREE BURN, AND WAS ALLERGIC TO THE PRODUCT. THEY EXPERIENCED SEVERE PAIN IN THE TREATED AREA, BUT DID NOT EXPERIENCE HIVES OR ITCHING. THEY WERE GIVEN SILVADENE CREAM, BANDAGED AND RELEASED. NO AREAS BECAME INFECTED. CUSTOMER WAS LATER SEEN BY PRIMARY CARE PHYSICIAN, AND REFERRED FOR PHYSICAL THERAPY AS THE 'BAD' AREAS ARE ON THEIR LEFT KNEE. SIX OF THE WORST AREAS STILL LOOK 'REALLY TERRIBLE', ACCORDING TO CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUND W FREEZE OFF WART REMOVAL SYSTEM GEH ORASURE TECHNOLOGIES, INC. * 0503ED3261E

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other