BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH II 15MM SPECIMEN POUCH

    MDR report key: 1458220 · Received May 21, 2009

    Report

    Report Number
    9612501-2009-00033
    Event Type
    Malfunction
    Date Received
    May 21, 2009
    Date of Event
    April 22, 2009
    Report Date
    April 24, 2009
    Manufacturer
    SANTO DOMINGO - USS
    Product Code
    GCJ
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REF #: US200905-0432. DATE OF INITIAL REPORT: 5/21/2009(B)(4). (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE BAG SPLIT OPEN WHEN THE DEVICE WAS PULLED OUT OF THE PT WITH THE SPECIMEN INSIDE. NO ILL EFFECTS TO THE PT WAS REPORTED. THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATCH II 15MM SPECIMEN POUCH SPECIMEN POUCH GCJ SANTO DOMINGO - USS J8M0020

    Patients

    Seq Age Sex Outcome Treatment
    1