BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 2946210 · Received January 4, 2013

    Report

    Report Number
    2647580-2013-00011
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 6, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    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: INGUENAL HERNIA REPAIR. ACCORDING TO THE REPORTER: DURING PROCEDURE, THE BALLOON WAS NOT INFLATED. IT WAS SUSPECTED THE PUMP OR BALLOON HAD A HOLE. NEW ONE WAS OPENED TO COMPLETE PROCEDURE. NO BLEEDING. TISSUE DAMAGE: UNKNOWN. NOTHING FELL INTO CAVITY. PATIENT STATUS: UNKNOWN. OPERATING ROOM TIME EXTENSION: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5754 SPACEMAKER PREPERITONEAL DIST BALLOON SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC P1J0087

    Patients

    Seq Age Sex Outcome Treatment
    1