BEUDAMED
    FDA Adverse Event Other Summary report: N

    8010282-2003-00001

    MDR report key: 835648 · Received February 5, 2004

    Report

    Report Number
    8010282-2003-00001
    Event Type
    Other
    Date Received
    February 5, 2004
    Product Code
    HAE
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN INSPECTING THE INSTRUMENT WE FOUND THAT THE HINGE PIN WAS BROKEN AND THE JAW WAS BENT, WHAT LEADS US TO THE CONCLUSION THAT THE INSTRUMENT HAD EITHER BEEN OVERSTRESSED OR MISUSED. THE STEEL CERTIFICATE FOR THE STEEL WIRE OF THIS BROKEN HINGE PIN INDICATES THAT THE STEEL MET ALL TECHNICAL REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAE

    Patients

    Seq Age Sex Outcome Treatment
    1