BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 3199549 · Received June 21, 2013

    Report

    Report Number
    1031623-2013-00006
    Date Received
    June 21, 2013
    Report Date
    October 6, 2008
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PQC SUMMARY: COMPLAINT COULD NOT BE VERIFIED AS A PRODUCT QUALITY ISSUE. PQC DATE: 15 DECEMBER 2008.

    Description of Event or Problem · 1

    REDNESS ON FOREARM [REDNESS]. CASE DESCRIPTION: COMPANY NARRATIVE: A SPONTANEOUS REPORT FROM A FEMALE CONSUMER (AGE NOT PROVIDED). THE CONSUMER'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. CONSUMER INITIATED DR. SCHOLL'S FREEZE AWAY COMMON AND PLANTAR WART REMOVER AS WART REMOVER (FREQUENCY, DATES OF THERAPY NOT PROVIDED). AN ON UNKNOWN DATE, THE CAN BLEW UP AND CAUGHT ON FIRE WITH FLAMES IN CONSUMER'S HANDS, BURNING HER HOUSECOAT, NAPKINS ON COFFEE TABLE AND CARPET. THE INCIDENT CAUSED REDNESS ON HER FOREARM. OUTCOME UNKNOWN. DECHALLENGE/RECHALLENGE INFORMATION NOT APPLICABLE. UPDATE (15 DECEMBER 2008): PQC ANALYSIS RESULTS RECEIVED. LOT 8B14CC WAS FILLED ON (B)(6) 2008 AND (B)(4) UNITS WERE PRODUCED. A REVIEW OF THE PRODUCTION LINE AND QUALITY INSPECTION RECORDS INDICATED THAT ALL SCHERING-PLOUGH SPECIFICATIONS AND REQUIREMENTS WERE MET THROUGHOUT THE RUN. A RETURNED SAMPLE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT WAS NOT RECEIVED BY KIK. ALL RETAIN UNITS WERE EXAMINED AND FOUND TO BE IN ORIGINAL MANUFACTURED CONDITION. THERE WAS NO EVIDENCE OF ANY CONDITION EXISTING DURING THE MANUFACTURING THAT COULD CONTRIBUTE TO THIS COMPLAINT. IT APPEARED THAT THE CONSUMER DID NOT FOLLOW PACKAGING INSTRUCTIONS AND HEED THE CLEAR PACKAGING WARNING SECTION. IN ORDER FOR ANY FIRE TO OCCUR, THREE CRITICAL ELEMENTS MUST BE PRESENT: A FUEL OR COMBUSTILE MATERIAL, AN IGNITION OR HEAT SOURCE, OXYGEN INSUFFICIENT QUANTITIES TO SUPPORT COMBUSTION. NO KIK SUPPLIED PORTION OF THIS PRODUCT COULD BE CONSIDERED AN IGNITION OR HEAT SOURCE. THIS APPEARS TO BE AN ISOLATED INCIDENT AS SP (B)(4) HAS NOT RECEIVED A COMPLAINT OF THIS NATURE FOR THIS PRODUCT. NO CORRECTIVE ACTIONS OR PREVENTIVE MEASURE WILL BE CONSIDERED ON THE PART OF OUR TPM. CONCLUSION: COMPLAINT COULD NOT BE VERIFIED AS A PRODUCT QUALITY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283748 DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER NONE GEH

    Patients

    Seq Age Sex Outcome Treatment
    1