BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 1130123 · Received August 19, 2008

    Report

    Report Number
    9612501-2008-00042
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 28, 2008
    Manufacturer
    SANTO DOMINGO - USS
    Product Code
    GCJ
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE BAG BROKE AND FELL INTO THE PT ABDOMINAL CAVITY. THERE WAS NO FURTHER COMPLICATION REPORTED. THE SURGERY WAS COMPLETED WITH NO REPORTED INJURY. THE PT SEX AND THE PROCEDURE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL ENDO SPECIMEN POUCH DEVICE GCJ SANTO DOMINGO - USS J8C002G

    Patients

    Seq Age Sex Outcome Treatment
    1