BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 883896 · Received July 20, 2007

    Report

    Report Number
    2090040-2007-00010
    Event Type
    Injury
    Date Received
    July 20, 2007
    Date of Event
    June 22, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NQG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVAL OF THE DEVICE AND THE COMPLETION OF THIS REPORT ARE ON HOLD UNTIL THE DEVICE CAN BE EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE HANDEL BROKE. THERE WAS NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NQG ASCENT HEALTHCARE SOLUTIONS XP-4000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention