BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCHOLL FREEZE VERRUCA AND WART REMOVER

    MDR report key: 4927712 · Received July 17, 2015

    Report

    Report Number
    3004142665-2015-00007
    Event Type
    Injury
    Date Received
    July 17, 2015
    Report Date
    July 1, 2015
    Manufacturer
    ORASURE TECHNOLOGIES INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACKAGE INSERT WARNS THAT MISUSE OF THE PRODUCT MAY RESULT IN BURNS OR PERMANENT SCARRING OF HEALTHY TISSUE OR BLINDNESS. USAGE DETAILS OF THE PRODUCT (I.E TIME OF CHARGE, TIME AFTER CHARGING, TIME OF APPLICATION, METHOD OF CHARGE, NUMBER OF TREATMENTS AND TIME BETWEEN TREATMENTS) WERE NOT PROVIDED. THEREFORE, SUFFICIENT INFORMATION IS NOT AVAILABLE TO DETERMINE IF THE PRODUCT WAS USED ACCORDING TO THE RECOMMENDED INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    A FEMALE CONSUMER REPORTED THAT SHE USED THE SCHOLL FREEZE VERRUCA AND WART REMOVER ON AN UNKNOWN DATE AND WHEN SHE WAS PUTTING THE PRODUCT BACK IN THE BOX, IT EXPLODED AND HIT HER IN THE FACE AND THE SPRAY GOT IN HER EYE. SHE STATED THAT THERE WAS NO LASTING DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465364 SCHOLL FREEZE VERRUCA AND WART REMOVER NA GEH ORASURE TECHNOLOGIES INC. 1001-0166 4304

    Patients

    Seq Age Sex Outcome Treatment
    1 Other