BEUDAMED
    FDA Adverse Event Summary report: N

    DR. SCHOLL'S SKIN TAG REMOVER

    MDR report key: 3199550 · Received June 21, 2013

    Report

    Report Number
    1031623-2013-00007
    Date Received
    June 21, 2013
    Report Date
    May 28, 2010
    Manufacturer
    SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K031697
    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: PQC RESULTS RECEIVED. IT IS WELL WRITTEN IN THE PRODUCT INSERT THAT THE PRODUCT IS HIGHLY FLAMMABLE AND MUST BE KEPT AT A DISTANCE FROM OPEN FLAMES OR SPARKS AND USED IN A WELL VENTILATED AREA. THE PRODUCT IS VOLATILE AND THE FUMES FROM THE PRODUCT MAY HAVE BEEN IGNITED BY A FLAME OF THE CANDLE AND CAUSED THE CAN TO CATCH FIRE. CONCLUSION: NO INVESTIGATION CAN BE DONE AND THE COMPLAINT COULD NOT BE VERIFIED AS THERE WAS NO RETURNED SAMPLE NOR REPORTED LOT NUMBER. PQC DATE: (B)(4) 2010.

    Description of Event or Problem · 1

    BURN FINGER ON [BURN]. CASE DESCRIPTION: COMPANY NARRATIVE: A SPONTANEOUS REPORT FROM A MALE CONSUMER (AGE NOT PROVIDED). THE CONSUMER'S MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE NOT PROVIDED. THE CONSUMER INITIATED DR. SCHOLL'S SKIN TAG REMOVER ON AN UNKNOWN DATE. THE PRODUCT WAS IN THE WASHROOM, AT LEAST ONE FOOT FROM LIGHTED CANDLES AND THE CANNISTER JUST GOT ON FIRE. WHEN HE GRABBED IT TO PUT IT IN THE SINK, UNDER THE WATER, THE CONSUMER BURNED HIS FINGERS. NO FURTHER DETAILS CAN BE OBTAINED FOR THIS CASE. THE OUTCOME IS UNKNOWN. DECHALLENGE/ RECHALLENGE INFORMATION NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282609 DR. SCHOLL'S SKIN TAG REMOVER NONE GEH SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1