BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1728510 · Received May 20, 2010

    Report

    Report Number
    2027111-2010-00064
    Event Type
    Malfunction
    Date Received
    May 20, 2010
    Date of Event
    April 8, 2010
    Report Date
    May 20, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RECEIVED AND IS UNDER ENGINEERING EVAL. WILL F/U WITHIN THIRTY DAYS.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: 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."

    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 CORP. CD001 1109149

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization