BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS BTT/OVAL BALLOON DISSECTOR

    MDR report key: 4161535 · Received July 23, 2014

    Report

    Report Number
    2647580-2014-00555
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 27, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA REPAIR. ACCORDING TO THE REPORTER: THE SPACEMAKER BALLOON DOES NOT WANT TO INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430741 SM PLUS BTT/OVAL BALLOON DISSECTOR SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P3K0724X

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR