BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP.INSTR.NON ARTICUL. D: 5/360MM

    MDR report key: 4862138 · Received June 17, 2015

    Report

    Report Number
    2916714-2015-00504
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 18, 2015
    Report Date
    March 30, 2016
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS NOT RETURNED TO BE ANALYZED. BECAUSE NO DEVICE WAS RETURNED AND LOT NUMBER WAS NOT REPORTED; ROOT CAUSE CAN NOT BE DETERMINED. NO CORRECTIVE/PREVENTIVE ACTION IS REQUIRED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    501 (K); K110824 ; K130596. MANUFACTURING SITE INVESTIGATION: EVALUATION ON-GOING AT MANUFACTURING SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). POST OPERATIVE ABDOMINAL BLEEDING (NEXT DAY). RE-OPERATION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392879 CAIMAN DISP.INSTR.NON ARTICUL. D: 5/360MM CUST AND SEAL DEVICE GEI AESCULAP AG & CO. KG PL720SU

    Patients

    Seq Age Sex Outcome Treatment
    1