BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 1850137 · Received September 22, 2010

    Report

    Report Number
    2647580-2010-00774
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE RPTR: THE BALLOON BURST INSIDE THE PT'S CAVITY WHILE INFLATING. THE BALLOON WAS PUMPED BETWEEN 30-40 TIMES. THE PIECES WERE RETRIEVED FROM THE CAVITY. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF UNANTICIPATED BLOOD/TISSUE LOSS, OR EXTENDED OPERATING ROOM TIME. NO PT 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 P0D0441

    Patients

    Seq Age Sex Outcome Treatment
    1