BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1212705 · Received October 22, 2008

    Report

    Report Number
    1056128-2008-00076
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NBH
    PMA / PMN Number
    K012611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT. UPON COMPLETION OF THE EVAL, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DEVICE EMITTED METAL SHAVINGS DURING THE PROCEDURE. METAL SHAVINGS WERE LEFT IN THE PT'S SHOULDER. NO OTHER ADVERSE OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NBH ASCENT HEALTHCARE SOLUTIONS 375-951-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other