BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD AUTO SUTURE SPECIMEN RETRIEVAL POUCH

    MDR report key: 10967388 · Received December 7, 2020

    Report

    Report Number
    MW5098250
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 25, 2020
    Report Date
    December 4, 2020
    Manufacturer
    COVIDIEN
    Product Code
    KDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDO CATCH BAG WAS DEPLOYED INSIDE THE PATIENT. THE APPENDIX WAS INSIDE. UPON REMOVAL THE BOTTOM OF THE BAG SPLIT OPEN INSIDE OF THE PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428842 ENDO CATCH GOLD AUTO SUTURE SPECIMEN RETRIEVAL POUCH CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, STERILE KDW COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR