BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER

    MDR report key: 3190464 · Received June 21, 2013

    Report

    Report Number
    1031623-2013-00001
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 23, 2010
    Product Code
    GEH
    PMA / PMN Number
    K031697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES AS RECEIVED FROM A CONSUMER REFERS TO A FEMALE PT OF UNKNOWN AGE. THIS REPORT CONCERNS ONE PT AND ONE DEVICE. ON AN UNKNOWN DATE, THE PT STARTED THERAPY WITH DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER) FOR WART. THE PT USED DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER) FOR WART. ON 2010, THE PT EXPERIENCED FLAME CAME OUT OF THIS CAN. THE OUTCOME OF FLAME CAME OUT OF THIS CAN IS UNKNOWN. THE REPORTER CONSIDERED FLAME CAME OUT OF THIS CAN TO BE RELATED TO DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER). THE DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER) WAS AVAILABLE FOR INVESTIGATION AND RETURNED TO MANUFACTURER ON (B)(4) 2010. FOR DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER), THE LOT NUMBER WAS REPORTED AS 9N01BKK AND THE SERIAL NUMBER IS NOT AVAILABLE. FOR DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER), QUALITY INVESTIGATION STATUS: LOT CHECK/BATCH REVIEW WAS PERFORMED. THE RESULT OF THE QUALITY INVESTIGATION IS AS FOLLOWS: (B)(4) 2010, (B)(4) COMPLAINT REPORT: THE COMPLAINT WAS NOT VERIFIED. THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. NO DEFECTS WERE NOTED. THIS IS THE FIRST COMPLAINT OF THIS NATURE RECEIVED FOR LOT 9N01BKKC. (B)(4) 2010 UPDATE: LETTER RECEIVED FROM CONSUMER STATING "CAUTION: HUGE FLAME MAY COME OUT OF CAN AND BURN YOUR FACE OFF OR SET YOUR HOUSE ON FIRE." THIS IS A FINAL REPORT FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282673 DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER UNIT, CRYOSURGICAL, ACCESSORIES (GEH) GEH 9N01BKK

    Patients

    Seq Age Sex Outcome Treatment
    1