BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELLEVE HANDPIECE

    MDR report key: 2519859 · Received April 4, 2012

    Report

    Report Number
    2428235-2012-00005
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Report Date
    November 10, 2011
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    PMA / PMN Number
    K082834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET REVIEW OF PELLEVE HANDPIECE COMPLAINTS LEAD TO REEVALUATION AND RECLASSIFICATION OF THIS COMPLAINT.

    Description of Event or Problem · 1

    WE WERE NOTIFIED THAT DURING A TREATMENT THE AESTHETICIAN HEARD 'INTERFERENCE' WITH THE RADIO JUST BEFORE SPARKS APPEARED FROM THE CABLE OF THE (B)(4) HANDPIECE. THE PT HAD BEEN USED APPROX 480 TIMES SINCE PURCHASE IN DECEMBER 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELLEVE HANDPIECE G E I GEI ELLMAN INT'L INC. D110FSHP 36818

    Patients

    Seq Age Sex Outcome Treatment
    1