BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2618282-2007-00012

    MDR report key: 921779 · Received August 17, 2007

    Report

    Report Number
    2618282-2007-00012
    Event Type
    Malfunction
    Date Received
    August 17, 2007
    Product Code
    KNW
    PMA / PMN Number
    PRE AMEN
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE SAMPLE WAS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE COMPLAINT HISTORY FOR LOT 5243702 REVEALED NO PRIOR INCIDENTS OF THIS TYPE. BASED ON THE AVAILABLE INFO AND LOT RECORDS, THIS INCIDENT DOES NOT APPEAR TO BE RELATED TO A MFG DEFECT, HOWEVER WITHOUT THE FAILURE SAMPLE FOR ANALYSIS WE ARE UNABLE TO CONFIRM THE CAUSE OF THE REPORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNW 5243702

    Patients

    Seq Age Sex Outcome Treatment
    1