BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH II 15MM SPECIMEN POUCH

    MDR report key: 1082162 · Received July 7, 2008

    Report

    Report Number
    9612501-2008-00034
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Report Date
    June 17, 2008
    Manufacturer
    SANTO DOMINGO - USS
    Product Code
    GCJ
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: BAG WAS NOT SEALED ON EITHER SIDE OF RIM. IT WAS NOT REPORTED IF THE PROBLEM WAS OBSERVED IN THE PT CAVITY OR NOT. NO FURTHER PT DETAILS OR PRODUCT ISSUE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1