BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPROCESSED CLIP APPLIER

    MDR report key: 2439469 · Received February 1, 2012

    Report

    Report Number
    2134070-2012-00002
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 6, 2012
    Report Date
    February 1, 2012
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CLIP APPLIER WAS CUTTING THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPROCESSED CLIP APPLIER CLIP APPLIER NMJ STERILMED, INC. ETHMCM20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention