BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 1993572 · Received January 21, 2011

    Report

    Report Number
    2647580-2011-00055
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Report Date
    December 23, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GEX
    PMA / PMN Number
    K946002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 REPORTER: THE BALLOON CAME LOOSE FROM THE PLASTIC AFTER IT WAS INFLATED. THE PT WAS NOT AFFECTED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250 CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER PREPERITONEAL DIST BALLOON DISPOSABLE SURGICAL ACCESS DEVICE GEX USSC PUERTO RICO P0A1104

    Patients

    Seq Age Sex Outcome Treatment
    1