BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP.INSTR.ARTICULAT.D5/360MM

    MDR report key: 5402769 · Received February 1, 2016

    Report

    Report Number
    2916714-2016-00080
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Report Date
    February 1, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K151696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 SIE EVALUATION: ON-GOING

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: GERMANY INSOLATION DETACHED DURING SURGERY; FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60045 CAIMAN DISP.INSTR.ARTICULAT.D5/360MM CUT AND SEAL DEVICE GEI AESCULAP AG PL741SU 52185110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other