BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 2011762 · Received February 14, 2011

    Report

    Report Number
    2647580-2011-00089
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 17, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: THE BALLOON DOES NOT INFLATE. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PATIENT. NO ADDITIONAL BLEEDING AND NO TISSUE DAMAGE WERE 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 PREPERITONEAL DIST BALLOON DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0B0189

    Patients

    Seq Age Sex Outcome Treatment
    1