BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR

    MDR report key: 3190448 · Received June 21, 2013

    Report

    Report Number
    1031623-2013-00003
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    September 29, 2008
    Product Code
    GEH
    PMA / PMN Number
    K031697
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NAME: WART REMOVER.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES AS RECEIVED FROM A CONSUMER REFERS TO A FEMALE PATIENT OF UNKNOWN AGE. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). IN (B)(6) 2008 THE PATIENT STARTED THERAPY WITH DIMETHYL ETHER (+) PROPANE. (DR. SCHOOL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER) FOR UNKNOWN INDICATION. THE PATIENT USED DIMETHYL ETHER (+) PROPANE (DR. SCHOOL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER) FOR UNKNOWN INDICATION. IN (B)(6) 2008 THE PATIENT EXPERIENCED SKIN IRRITATED AND EXPLODED ON ME. THERAPY WITH DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER) WAS DISCONTINUED. THE OUTCOME OF SKIN IRRITATED AND EXPLODED ON ME IS UNKNOWN. THE REPORTER CONSIDERED SKIN IRRITATED AND EXPLODED ON ME RELATED TO DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER). THE DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER) WAS NOT AVAILABLE FOR INVESTIGATION. FOR DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER), THE LOT NUMBER IS NOT AVAILABLE AND THE SERIAL NUMBER IS NOT AVAILABLE. THIS IS A FINAL REPORT FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283710 DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR UNIT, CRYOSURGICAL, ACCESSORIES (GEH) GEH 6G10CC

    Patients

    Seq Age Sex Outcome Treatment
    1