BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCATCH BAG

    MDR report key: 16304629 · Received February 3, 2023

    Report

    Report Number
    MW5114689
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 18, 2023
    Report Date
    February 1, 2023
    Manufacturer
    MEDTRONIC - COVIDIEN
    Product Code
    KDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ENDO CATCH BAG BROKE UPON PULLING SPECIMEN OUT OF BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99500 ENDOCATCH BAG CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, STERILE KDW MEDTRONIC - COVIDIEN FEP936116B 6252106192

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female