BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 2935805 · Received January 2, 2013

    Report

    Report Number
    2647580-2012-00822
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 5, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GEX
    PMA / PMN Number
    K946002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: PROSTATECTOMY. ACCORDING TO THE REPORTER: USED FOR LAP. PROSTATECTOMY. SOUND OF AIR LEAKING WAS HEARD AND THE BALLOON WAS NOT INFLATED. THE SURGEON REMOVED THE DEVICE FROM THE CAVITY AND RE-INSERTED, BUT STILL THE BALLOON WAS NOT INFLATED. NEW DEVICE WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425 SPACEMAKER PREPERITONEAL DIST BALLOON SPACEMAKER BALLOON GEX COVIDIEN, FORMERLY USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1