BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELLEVE HANDPIECE

    MDR report key: 2519860 · Received April 4, 2012

    Report

    Report Number
    2428235-2012-00003
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 9, 2012
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    PMA / PMN Number
    K0822834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A TREATMENT WITH THE 15MM HANDPIECE, ONE HOUR INTO THE TREATMENT, THE USER HEARD A STATIC, SIZZLING SOUND FOLLOWED BY A BIT OF SMOKE AND A LITTLE SPARK. THE PT WAS NOT AFFECTED. THE AESTHETICIAN WAS USING THE FOOTPEDAL. THE CABLE WAS NOT COILED. THIS HANDPIECE WAS USED APPROX 20 TIMES SINCE PURCHASING IN MARCH 2011. THE GENERATOR SETTING WAS 25. GAUZE WITH ALCOHOL IS USED TO STERILIZE THE HANDPIECE BETWEEN PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELLEVE HANDPIECE G E I GEI ELLMAN INT'L INC. D115FSHP 36819

    Patients

    Seq Age Sex Outcome Treatment
    1