BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR

    MDR report key: 3946220 · Received July 8, 2014

    Report

    Report Number
    1031623-2014-00006
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    June 8, 2014
    Product Code
    GEH
    PMA / PMN Number
    K031697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IN PROGRESS. EVENT DESCRIPTION: COMMON & PLANTAR WART REMOVER WAS NOT AVAILABLE FOR INVESTIGATION. FOR DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER), THE LOT NUMBER WAS NOT AVAILABLE AND THE SERIAL NUMBER WAS NOT AVAILABLE. ADD'L INFO HAS BEEN REQUESTED. UPDATE (B)(4) 2014: LOT NUMBER 3601FKK WAS AN INVALID LOT NUMBER FOR DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER). QUESTIONNAIRE REC'D (B)(4) 2014 AND REVIEWED. DEMOGRAPHIC INFO UPDATED. UPON REVIEW OF QUESTIONNAIRE, IT WAS NOTED THAT THIS CASE SHOULD HAVE BEEN CAPTURED AS A DEVICE INCIDENT ON (B)(6) 2014. THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES AS REC'D FROM A CONSUMER REFERS TO A (B)(6) YEAR OLD WHITE FEMALE CONSUMER, WHO PURCHASED THE PRODUCT FOR HER SON'S WART (NEW INDICATION). ON (B)(6) 2014 THE PATIENT STARTED THERAPY WITH DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER) (2 DF, ONCE), LOT # 3G01FKK (NEW LOT# PROVIDED BY CONSUMER) EXP DATE JUNE-2014. THE PATIENT USED DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER) FROM (B)(6) 2014 UP TO (B)(6) 2014 FOR A WART.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT ORIGINATING FROM THE UNITE STATES AS REC'D FROM A CONSUMER REFERS TO A FEMALE PATIENT OF UNKNOWN AGE. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH DEMETHYL ETHER (+)PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER), LOT # 3601FKK WITH EXPIRATION OF JUNE 2014, FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT WAS SCARED AND ANGRY THAT THE PRODUCT CAUGHT ON FIRE. NO OTHER CO-SUSPECTS WERE REPORTED. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE OUTCOME OF BEING ANGRY AND SCARED BY THE PRODUCT CATCHING ON FIRE WAS UNKNOWN. THE REPORTER CONSIDERED BEING SCARED AND ANGRY 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 ON (B)(6) 2014. THE PATIENT EXPERIENCED "PRODUCT CAUGHT ON FIRE" WHILE "USING IT NEAR A BURNING CANDLE 2 FEET AWAY (MEDICALLY SIGNIFICANT)." THERAPY WITH DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WAR REMOVER) WAS DISCONTINUED ON (B)(6) 2014. THE OUTCOME OF USING IT NEAR A BURNING CANDLE 2 FEET AWAY, ANGRY, SCARED AND PRODUCT CAUGHT ON FIRE IS UNKNOWN. THE DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER) WAS RETURNED AND IS AVAILABLE FOR INVESTIGATION. FOR DIMETHYL ETHER (+) PROPANE (DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER), QUALITY INVESTIGATION STATUS: INVESTIGATION IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395562 DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR UNIT, CRYOSURGICAL, ACCESSORIES (GEH) GEH 3G01FKK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other