BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCHOLL FREEZE VERRUCA AND WART REMOVER

    MDR report key: 2997381 · Received March 7, 2013

    Report

    Report Number
    3004142665-2013-00001
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ORASURE TECHNOLOGIES INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HIS FINGER SWELLED UP AFTER USING THE SCHOLL FREEZE VERRUCA AND WART REMOVER PRODUCT. THE FREEZE PRODUCT WAS USED TO TREAT A WART ON THE INDEX FINGER OF THE RIGHT HAND OF THE CONSUMER. THE CONSUMER STATED THAT HE CHARGED THE CANISTER FOR 15 SECONDS AND WAITED 5 SECONDS BEFORE APPLYING THE APPLICATOR BUD TO THE WART FOR 30 SECONDS. THE PACKAGE INSTRUCTIONS STATES ¿KEEPING THE CAN UPRIGHT AND HOLDING AS SHOWN, PRESS THE CAP DOWN FOR 5 SECONDS¿ AND ¿YOU MUST WAIT FOR 15 SECONDS, HOLDING THE BUD POINTING DOWNWARDS BEFORE APPLYING TO THE VERRUCA OR WART.¿ THE PATIENT REPORTED THAT HE DID THIS TREATMENT ON TUESDAY OR WEDNESDAY AND THE DAY AFTER HE WOKE UP AND HIS FINGER HAD SWELLED UP LIKE A BALLOON. ON THE FRIDAY OF THAT WEEK, HE WAS ADMITTED TO THE HOSPITAL, WHERE HE STAYED UNTIL THE FOLLOWING MONDAY. THE PATIENT REPORTED THAT THE DOCTOR HAD TOLD HIM THAT HE HAD CELLULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97770 SCHOLL FREEZE VERRUCA AND WART REMOVER NONE GEH ORASURE TECHNOLOGIES INC. 1001-0166 1102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization