BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 494319 · Received November 4, 2003

    Report

    Report Number
    2528909-2003-00002
    Event Type
    Other
    Date Received
    November 4, 2003
    Report Date
    November 3, 2003
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED 10/03 THAT AFTER USING COMPOUND W FREEZE OFF A VISIT TO THE EMERGENCY ROOM WAS REQUIRED. SELF-TREATMENT OF WARTS ON FINGERS AND TOES CAUSED VERY BAD BLISTERS. OPERATOR ADVISED THAT BLISTERS WERE NORMAL; CUSTOMER FELT THESE WERE WORSE THAN REPRESENTATIVE'S DESCRIPTION. CUSTOMER CALLED SECOND TIME SAME DAY WITH MORE INFO. DR AT EMERGENCY ROOM SAW CUSTOMER, DIAGNOSIS WAS CHEMICAL BURNS ON THEIR HANDS WHERE CUSTOMER TREATED WARTS. CUSTOMER REPORTED ONLY ONE APPLICATION OF PRODUCT. CUSTOMER CALLED THIRD TIME SAME DAY WITH ADDITIONAL INFO. CUSTOMER TREATED 8 WARTS ON LEFT HAND AND 1 ON RIGHT HAND AND THEIR FOOT. CUSTOMER STATED PRODUCT WAS SELF-APPLIED AS DIRECTED. RELATED THAT ALL TREATED WARTS STARTED TO BLISTER BUT MOST BLISTERS POPPED ON THEIR OWN. EMERGENCY ROOM DR PRESCRIBED TRIPLE ANTIBIOTIC OINTMENT TO TREAT AREA. CUSTOMER REPORTED THAT ALL TREATED WARTS HAVE TURNED RED EXCEPT FOR ONE LARGER WART LOCATED ON RIGHT HAND, WHICH CUSTOMER REPORTED AS A HUGE HOLE. A FOLLOW-UP CALL A WEEK LATER CUSTOMER REPORTED HEALING AND GOING TO THE DR'S, AND HAD ONLY ONE REALLY BAD SPOT LEFT ON THEIR ANKLE, BUT IT WAS HEALING. STILL LITTLE RED SCARS OR WHATEVER, BUT NOT BLISTERING OR OOZING. CUSTOMER WENT TO E.R. TWICE AND THEIR REGULAR DR TWICE. CUSTOMER CHANGED THE BAND-AIDS. CUSTOMER DID NOT THINK THE WARTS WERE REMOVED. COULDN'T REALLY TELL BECAUSE IT WAS SO MESSED UP. CUSTOMER DID NOT KNOWN WHAT DAY THE PRODUCT WAS USED. CUSTOMER WILL HAVE TO LOOK AT DATES. CUSTOMER WENT TO THE E.R. TWICE IN OCT 2003. THEY FELT THAT IT WAS WORSE ON THEIR RIGHT HAND AND REACTED MORE THAN JUST THE "BLISTER". CUSTOMER COULD NOT REMEMBER USING ONE APPLICATOR FOR EACH WART, CUSTOMER THOUGHT OF HAVING EIGHT OR TEN WARTS. CUSTOMER BELIEVED THE WARTS WERE STILL THERE (STILL USING BAND-AIDS). CUSTOMER CALLED 9 WEEKS LATER AND REPORTED SCARRING ON HANDS, BUT STILL HEALING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention