BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 3190591 · Received June 13, 2013

    Report

    Report Number
    2647580-2013-00326
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: THE HERNIA BALLOON, WHEN INFLATED, BURST. NOTHING FELL INTO THE CAVITY. A NEW INSTRUMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270488 SPACEMAKER PREPERITONEAL DIST BALLOON SPACE MAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P3A06418

    Patients

    Seq Age Sex Outcome Treatment
    1