BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAG 4X6 10M 225ML VOL, MONARCH RETRIEVAL BAG

    MDR report key: 1635507 · Received March 17, 2010

    Report

    Report Number
    2027111-2010-00041
    Event Type
    Other
    Date Received
    March 17, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 16, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAP CHOLE - "AS THE SURGEON (DR. (B)(6)) WAS PULLING THE SPECIMEN AND BAG THROUGH THE ABDOMEN, THE BAG BUSTED FROM THE BOTTOM. IT WAS BEING PULLED THROUGH A BLADED 11MM APPLIED PORT SITE." "PULLING STONES FROM ABDOMEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAG 4X6 10M 225ML VOL, MONARCH RETRIEVAL BAG MONARCH RETRIEVAL BAG GCJ APPLIED MEDICAL RESOURCES CD001 1107578

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention