BEUDAMED
    FDA Adverse Event Other Summary report: N

    8010488-2008-00001

    MDR report key: 1309024 · Received November 28, 2008

    Report

    Report Number
    8010488-2008-00001
    Event Type
    Other
    Date Received
    November 28, 2008
    Product Code
    GFA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE INSTRUMENT WAS RETURNED FOR EVAL NOR THE LOT NUMBER WAS PROVIDED. THEREFORE, WE WERE UNFORTUNATELY NOT IN A POSITION TO TRACE BACK THE INSTRUMENT TO ITS MFG DATE. PERFORMING A TREND ANALYSIS. THIS TYPE OF ARTICLE TO THE DISTRIBUTOR SINCE 2003. WE STARTED PRODUCTION OF THIS ITEM IN 1970 AND MFR A TOTAL OF APPROX 50000 PCS A YEAR. SO FAR, WE HAVE NOT BEEN MADE AWARE OF A COMPLAINT OF THIS NATURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1