BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS BTT/ROUND BALLOON DISSECTOR

    MDR report key: 4200479 · Received October 24, 2014

    Report

    Report Number
    2647580-2014-00913
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    October 6, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: BALLOON DID NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678978 SM PLUS BTT/ROUND BALLOON DISSECTOR SPACE MAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC SMBTTRND P4E0432X

    Patients

    Seq Age Sex Outcome Treatment
    1