BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTOR 24KHZ NEURO SHORT HANDPIECE

    MDR report key: 2602646 · Received June 4, 2012

    Report

    Report Number
    8010219-2012-00015
    Event Type
    Malfunction
    Date Received
    June 4, 2012
    Report Date
    June 4, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE SECOND REPORT INVOLVING A 24 KHZ HAND PIECE (DIFFERENT LOT NUMBER) FROM THE SAME FACILITY. CROSS REFERENCE WITH MFR 801219-2012-00014 (B)(4). A 24 KHZ SHORT HAND PIECE THAT WAS BEING USED DURING A PROCEDURE WAS HEATING UP TO AN EXCESSIVE TEMP AND THE POWER WAS NOT CONSISTENT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTOR 24KHZ NEURO SHORT HANDPIECE NA LFL INTEGRA NEUROSCIENCES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1