BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTOR 35KHZ NEURO HANDPIECE

    MDR report key: 3901761 · Received May 8, 2014

    Report

    Report Number
    8010219-2014-00018
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    LFL
    PMA / PMN Number
    K021989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WAS GETTING EXTREMELY HOT. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(6) 2014 AND (B)(6) 2014, THE FOLLOWING WAS RECEIVED FROM THE CUSTOMER (BIOMED): ON (B)(6) 2014, THE DOCTOR WAS HOLDING THE HANDPIECE IN HIS HAND AND IT GOT EXTREMELY HOT. THE DOCTOR COULD NOT HOLD IT ANY MORE AND HAD TO PUT IT DOWN. THE INCIDENT OCCURRED DURING THE MIDDLE OF THE SURGERY. PATIENT AGE, GENDER, AND TYPE OF SURGERY WERE NOT PROVIDED. THERE WAS NO PATIENT OR USER INJURY. A REPLACEMENT PRODUCT WAS AVAILABLE TO BE USED. PATIENT OUTCOME WAS REPORTED AS "SUCCESSFUL SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279052 SELECTOR 35KHZ NEURO HANDPIECE NA LFL INTEGRA NEUROSCIENCES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1