BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1210886 · Received June 17, 2008

    Report

    Report Number
    1527736-2008-03767
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Product Code
    GDO
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFO, THE MFG RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MFG OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER GDO

    Patients

    Seq Age Sex Outcome Treatment
    1