BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 3800310 · Received May 2, 2014

    Report

    Report Number
    2647580-2014-00331
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 7, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE BALLOON WOULD NOT INFLATE DURING THE SURGERY. CONVERTED TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264246 SM PLUS SBT/OVAL BALLOON DISSECTOR SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P3M0630X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other