BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3190443 · Received June 21, 2013

    Report

    Report Number
    1031623-2013-00002
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    August 28, 2003
    Product Code
    GEH
    PMA / PMN Number
    K031697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    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). ON AN UNKNOWN DATE THE PATIENT STARTED THERAPY WITH DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER) FOR UNKNOWN INDICATION. THE PATIENT USED DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER) FOR UNKNOWN INDICATION. ON 2006 THE PATIENT EXPERIENCED FLAMES COMING FROM BOTH THE CAP AND THE APPLICATOR TIP. THE OUTCOME OF FLAMES COMING FROM BOTH THE CAP AND THE APPLICATOR TIP IS UNKNOWN. THE REPORTER CONSIDERED FLAMES COMING FROM THE BOTH THE CAP AND THE APPLICATOR TIP TO BE 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 AVAILABLE FOR INVESTIGATION AND RETURNED TO MANUFACTURER ON (B)(6) 2006. FOR DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER), THE LOT NUMBER WAS REPORTED AS 6G10CC AND THE SERIAL NUMBER IS NOT AVAILABLE. FOR DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER), QUALITY INVESTIGATION STATUS: LOT CHECK/BATCH REVIEW WAS PERFORMED. THE RESULTS OF THE QUALITY INVESTIGATION IS AS FOLLOWS: (B)(6) 2006 AND COMPLAINT REPORT: THE COMPLAINT COULD NOT BE VERIFIED. (B)(4) 2006 UPDATE: CALLED CONSUMER AND THERE WAS A CANDLE BURNING IN THE BATHROOM BUT IT WAS ON THE OTHER SIDE OF THE ROOM. SHE IS A NON-SMOKER. SHE HAD NOT DONE ANY CLEANING IN THE BATHROOM. THIS IS THE FINAL REPORT FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282395 DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER UNIT, CRYOSURGICAL, ASSCEESORIES (GEH) GEH 6G10CC

    Patients

    Seq Age Sex Outcome Treatment
    1