BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 3960957 · Received May 23, 2014

    Report

    Report Number
    2647580-2014-00381
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: TEP. ACCORDING TO THE REPORTER: THE BALLOON WOULD NOT HOLD AIR WHEN THEY TRY TO INFLATE IT. USED A SECOND DEVICE WITHOUT ISSUE. PURCHASING MANAGER DID NOT HAVE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309317 SM PLUS SBT/OVAL BALLOON DISSECTOR SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC P3M0630X

    Patients

    Seq Age Sex Outcome Treatment
    1