BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON 2EZEE SPECIMEN RETRIEVAL BAG

    MDR report key: 10394466 · Received August 11, 2020

    Report

    Report Number
    3002590791-2020-00084
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    May 14, 2019
    Report Date
    August 11, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GCJ
    UDI-DI
    00877972007289
    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 THROUGH DECEMBER 2019. THIS IS FOR THE 3RD OF 3 TOTAL DEVICES LISTED IN THE COMPLAINT.

    Description of Event or Problem · 1

    TWO DOCTORS ON THE TRAUMA/SURGERY TEAM USED THREE BAGS IN THREE CASES AND EACH ONE RIPPED WHILE ATTEMPTING TO EXTRACT THE SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853622 GENICON 2EZEE SPECIMEN RETRIEVAL BAG SPECIMEN RETRIEVAL BAG GCJ GENICON, INC. 550-000-200 I9824-A 00877972007289

    Patients

    Seq Age Sex Outcome Treatment
    1