BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN ENDO CATCH II

    MDR report key: 10343712 · Received July 29, 2020

    Report

    Report Number
    MW5095794
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 15, 2020
    Report Date
    July 27, 2020
    Manufacturer
    COVIDIEN
    Product Code
    KDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDO CATCH 11 SPECIMEN RETRIEVAL POUCH WAS BEING USED BY PHYSICIAN TO EXTRACT SPECIMEN FROM ABDOMEN AND THE BOTTOM OF POUCH BROKE AT THE SEAM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805936 COVIDIEN ENDO CATCH II CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, STERILE KDW COVIDIEN 173049 J0E1669HY

    Patients

    Seq Age Sex Outcome Treatment
    1