BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1212703 · Received October 22, 2008

    Report

    Report Number
    1056128-2008-00075
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE DEVICE IS RETURNED TO ASCENT HEALTHCARE SOLUTIONS, AN EVAL OF THE SUBJECT DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE EVALUATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE DEVICE WHEN PART OF THE LOWER JAW AND TISSUE PAD BURNED OFF. THE PIECES WERE SUCCESSFULLY RETRIEVED AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NLQ ASCENT HEALTHCARE SOLUTIONS ACE36P

    Patients

    Seq Age Sex Outcome Treatment
    1