BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 1010121 · Received March 10, 2008

    Report

    Report Number
    9612501-2008-00014
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    SANTO DOMINGO - USS
    Product Code
    GCJ
    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 DURING UTILIZATION AND NO PT INJURY WAS REPORTED. ANOTHER ONE WAS APPLIED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL SPECIMEN POUCH GCJ SANTO DOMINGO - USS J7H03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK