BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER EXTRA VIEW BALLOON - ROUND

    MDR report key: 2904767 · Received December 4, 2012

    Report

    Report Number
    2647580-2012-00764
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    June 29, 2012
    Report Date
    November 5, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K954175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE BALLOON DID NOT INSUFFLATE WHEN IN ABDOMEN. THE DEVICE IS BEING RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER EXTRA VIEW BALLOON - ROUND SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P1K0416

    Patients

    Seq Age Sex Outcome Treatment
    1