BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCHOLL FRREZE VERRUCA AND WART REMOVER

    MDR report key: 2470720 · Received January 3, 2012

    Report

    Report Number
    2528909-2011-00002
    Event Type
    Injury
    Date Received
    January 3, 2012
    Date of Event
    November 10, 2011
    Report Date
    December 5, 2011
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL COMPLAINT WAS TRANSLATED FROM (B)(6) TO ENGLISH. THE CUSTOMER INDICATED THAT THERE WERE A COUPLE OF CANDLES ON THE OTHER SIDE OF THE TABLE. NO EXACT DISTANCE WAS CITED BY THE CUSTOMER. THE WIDTH OF THE TABLE WAS NOT PROVIDED. SHE STATED THAT A FEW DROPLETS REACHED THE OTHER SIDE OF THE TABLE. SHE DID NOT INDICATE THE MANNER IN WHICH THIS OCCURRED. SHE BELIEVES THE GAS THAT LEAKED FROM THE CANISTER IGNITED WHEN IT SPRAYED OUT FROM THE CANISTER. SHE ACKNOWLEDGED THAT THE PACKAGING STATES THAT THE CONTAINER SHOULD BE STORED AWAY FROM FLAMES, BUT DID NOT FEEL THE CANDLES WERE CONSIDERED CLOSE. SHE ALSO ACKNOWLEDGED THE PRINTED HAZARD WARNING ON THE PACKAGING THAT STATES THAT THIS PRODUCT IS HIGHLY FLAMMABLE AND SHOULD NOT BE SPRAYED NEAR OPEN FLAME. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION FOR THE BLISTERS ON HER HAND OR THE IRRITATION IN HER EYE. SHE STATED THAT SHE RINSED HER HAND AND EYE WITH COLD WATER AND FELT MUCH BETTER AFTER DOING SO. SHE REFUSED TO RETURN THE PRODUCT. THE CUSTOMER ALSO DID NOT PROVIDE THE LOT NUMBER OF THE PRODUCT. WITHOUT A LOT NUMBER, SAMPLE RETAIN TESTING CANNOT BE PERFORMED. WITHOUT EVALUATION OF THE RETURNED PRODUCT, NO DEFINITIVE OR CONTRIBUTING CAUSES CAN BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER, LOCATED IN (B)(6), WAS USING THE SCHOLL FREEZE VERRUCA AND WART REMOVER PRODUCT. WHEN THE CUSTOMER PRESSED DOWN ON THE ACTUATOR TO DISPENSE THE CRYOGEN, THERE WAS A LOUD SOUND AND THE CUSTOMER FELT TINY DROPLETS OF FLUID LEAKING OUT FROM THE CANISTER. THE LOCATION OF THE LEAK WAS NOT IDENTIFIED. IT SPRAYED OVER THE CUSTOMER'S RIGHT HAND AND UP INTO HER FACE. AT THE SAME TIME, THE FLUID CAUGHT FIRE WHILE SPRAYING THE CUSTOMER'S HAND AND FACE. THE CUSTOMER EXTINGUISHED THE FIRE BY BLOWING THE SMOTHERING THE FIRE WITH PAPER AND HER HANDS. THIS INCIDENT CAUSED MINOR BLISTERS TO THE CUSTOMER'S RIGHT HAND AND A SLIGHT IRRITATION TO HER RIGHT EYE. THE CUSTOMER DID NOT SEEK MEDICAL TREATMENT. SHE RINSED HER HAND AND EYE WITH COLD WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCHOLL FRREZE VERRUCA AND WART REMOVER NONE GEH ORASURE TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other