BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 898128 · Received August 14, 2007

    Report

    Report Number
    2528909-2007-00002
    Event Type
    Other
    Date Received
    August 14, 2007
    Report Date
    August 10, 2007
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS NOT RETURNED THE CANISTER FOR EVALUATION. ORASURE TECHNOLOGIES, INC HAS PERFORMED FUNCTIONAL TESTING ON CANISTERS FROM THIS PRODUCTION LOT AND ALL RESULTS MET PRODUCT SPECIFICATION. NO DEFECTS WERE DETECTED DURING RELEASE TESTING FOR THIS PRODUCTION LOT. REVIEW OF PRODUCT INSTRUCTION INSERT: WARNINGS SECTION: "USE ONLY AS DIRECTED. MISUSE OF COMPOUND W FREEZE OFF MAY RESULT IN BURNS AND PERMANENT SCARRING OF HEALTHY TISSUE OR BLINDNESS." "DO NOT SPRAY GAS DIRECTLY ONTO SKIN, AS BURNS AND PERMANENT SCARRING OF THE SKIN MAY RESULT." DIRECTIONS FOR USE: "DO NOT HOLD THE SPRAY CAN NEAR YOUR FACE, OVER PARTS OF YOUR BODY OR CLOTHING." "DO NOT LET ANY LIQUID MAKE CONTACT WITH YOUR SKIN." ORASURE TECHNOLOGIES, INC RECEIVED ONE SIMILAR REPORT WHERE THE LIQUID WAS RUNNING DURING CHARGE OF APPLICATOR. THAT CANNISTER WAS RETURNED AND THE REPORT WAS NOT CONFIRMABLE, THE PRODUCT PERFORMED AS DESIGNED.

    Description of Event or Problem · 1

    ON JULY 17, A CUSTOMER REPORTS THAT HER DAUGHTER USED FREEZE OFF WITH CUSTOMER (MOTHER) STANDING BY AND THE PRODUCT SHOT BACK AT THEM BOTH SPRAYING OVER THE CHILD'S KNEE AND LEG AND THE MOTHER'S LIPS AND HAND. CUSTOMER CALL ON JULY 26 TO PROVIDE ADDITIONAL INFORMATION AND STATED THE FOLLOWING: SHE INSERTED THE APPLICATOR ONTO A FREEZE OFF CANISTER, SAT THE CANISTER ON THE EDGE OF THE BATH TUB AND PRESSED THE ACTUATOR TO SATURATE THE APPLICATOR. AT THIS TIME, HER DAUGHTER WAS SITTING ON THE BENCH PORTION OF THE BATHTUB. WHEN THE MOTHER LIFTED THE CANISTER TO APPLY THE APPLICATOR TO THE WART LIQUID SPRAYED OUT OF THE CAN ONTO HER DAUGHTER'S LEG, LIPS AND HAND. THE CHILD WAS TAKEN TO A PHYSICIAN THE NEXT DAY. DAUGHTER HAS GONE TO THE PHYSICIAN EIGHT DAYS IN A ROW FOR TREATMENT OF THE INJURED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUND W FREEZE OFF FREEZE OFF-CRYOSURGICAL WART REMOVER SYS. GEH ORASURE TECHNOLOGIES, INC. 6074

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other