BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    MDR report key: 1981457 · Received January 11, 2011

    Report

    Report Number
    2647580-2011-00028
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 16, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: THE BALLOON BECAME DETACHED UPON INSERTION OF GRAFT. THE BROKEN BALLOON WAS REMOVED FROM THE CAVITY. NO ADDITIONAL BLEEDING AND NO TISSUE DAMAGE WAS REPORTED. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER STRUCTURAL BALLOON TROCAR DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0J1035

    Patients

    Seq Age Sex Outcome Treatment
    1