BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGATURE CLIP 12 MAG.= 144 PCS.

    MDR report key: 5411475 · Received February 4, 2016

    Report

    Report Number
    2916714-2016-00086
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    March 5, 2015
    Report Date
    February 4, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    FZP
    PMA / PMN Number
    K081031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018 MANUFACTURING SITE EVALUATION: ON-GOING

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: FRANCE CLIPS JAMMED; UNABLE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69192 LIGATURE CLIP 12 MAG.= 144 PCS. LIGATURE CLIP FZP AESCULAP AG PL572T 52053327

    Patients

    Seq Age Sex Outcome Treatment
    1 Other