BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTOR 35KHZ NEURO HANDPIECE

    MDR report key: 4152430 · Received October 3, 2014

    Report

    Report Number
    8010219-2014-00052
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    LFL
    PMA / PMN Number
    K021989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A 153200M9 SELECTOR 35KHZ NEURO HANDPIECE LEAKED AND OVERHEATED DURING A CRANIOTOMY. THERE WAS NO INJURY INVOLVED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617502 SELECTOR 35KHZ NEURO HANDPIECE NA LFL INTEGRA NEUROSCIENCES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1