BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON 2EZEE

    MDR report key: 10402026 · Received August 13, 2020

    Report

    Report Number
    3002590791-2020-00099
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 19, 2019
    Report Date
    August 13, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K180836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A REVIEW OF COMPLAINT FILES BETWEEN OCTOBER 2017 THOUGH DECEMBER 2019.

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO UTILIZE THE BAGS, THE BAGS TORE UPON REMOVAL THROUGH THE DEFECT. TEARS WERE AT THE BOTTOM OF THE BAG ON 3 OF THE BAGS. A NEW BAG WAS USED EACH TIME. A DIFFERENT BAG TORE APART INTO MULTIPLE PIECES. AS A RESULT THE SCRUB TECH HAD TO PIECE THE BAG BACK TOGETHER ON THE BACK TABLE TO ENSURE ALL THE PIECES WERE REMOVED FROM THE PATIENT'S ABDOMEN. FACILITY CANNOT LOCATE BAGS FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865301 GENICON 2EZEE POLY SPECIMEN RETREIVAL BAG GCJ GENICON, INC. 550-000-200 J0468-B

    Patients

    Seq Age Sex Outcome Treatment
    1