BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CATH II 15MM SPECIMEN POUCH

    MDR report key: 1083295 · Received July 28, 2008

    Report

    Report Number
    9612501-2008-00037
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 2, 2008
    Manufacturer
    SANTO DOMINGO - USS
    Product Code
    GCJ
    PMA / PMN Number
    K922123
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY REINFORCEMENT REPAIR OF HIATAL HERNIA. ACCORDING TO THE REPORTER: HALF OF SACK WAS TORN AWAY FROM METAL RIM ALONG PERFORATIONS. IT COULD NOT BE CLOSED UP AND PULLED THROUGH THE TROCAR. PATIENT STATUS IS WELL. ANOTHER DEVICE OF THE SAME KIND WAS USED. RIGHT ADNEXAL MASS. THERE WAS A POSSIBLE TISSUE DAMAGE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATH II 15MM SPECIMEN POUCH SURGICAL SPECIMEN POUCH GCJ SANTO DOMINGO - USS J7G28

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention