BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 1993609 · Received January 24, 2011

    Report

    Report Number
    2647580-2011-00066
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 12, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: THE BALLOON WOULD NOT INFLATE. ANOTHER DEVICE WAS USED. THERE WAS NO BLEEDING OR TISSUE DAMAGE, NOTHING FELL INTO THE PT CAVITY, NOR WAS THE OPERATING ROOM TIME EXTENDED MORE THAN 30 MINS. NO PT INJURY 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 P0K0973

    Patients

    Seq Age Sex Outcome Treatment
    1