BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELLEVE HANDPIECE

    MDR report key: 2491775 · Received March 9, 2012

    Report

    Report Number
    2428235-2012-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 9, 2012
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    PMA / PMN Number
    K082834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AESTHETICIAN REPORTED THAT THE 15MM HANDPIECE SPARKED AND THE CABLE OFF BROKE NEAR THE HANDLE WHILE PERFORMING A FULL FACE SKIN TIGHTENING TREATMENT. NEITHER THE USER NOR THE PATIENT WAS HARMED OR INJURED. THE HANDPIECE HAD BEEN USED APPROXIMATELY 120 TIMES. THE GENERATOR POWER SETTING WAS 20 AT TIME OF EVENT. THE HANDPIECE HAD BEEN IN USE FOR 10-15 MINUTES WHEN THE EVENT OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1