BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM SHORT SECONDARY PORT

    MDR report key: 1001137 · Received February 15, 2008

    Report

    Report Number
    2647580-2008-00075
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 14, 2008
    Report Date
    January 18, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: INGUENAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE INTERNAL SEAL BROKE APART WHILE THE SURGEON WAS INSERTING THE DEVICE. SURGEON ALSO HAD TO REMOVE A PIECE OF THE RUBBER SEAL FROM THE PT'S CAVITY. A NEW DEVICE WAS OPENED FOR THE PROCEDURE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM SHORT SECONDARY PORT SURGICAL ACCESS DEVICE GCJ PONCE - USS P7K1069

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK