BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 2935806 · Received January 2, 2013

    Report

    Report Number
    2647580-2012-00817
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    October 19, 2012
    Report Date
    December 3, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE BALLOON WAS FOUND BROKEN WHILE SURGEON PERFORMED THE SURGERY. THE SURGERY WAS COMPLETED BY USING A NEW DEVICE. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529 SPACEMAKER PREPERITONEAL DIST BALLOON SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO PSD0418

    Patients

    Seq Age Sex Outcome Treatment
    1