BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS BTT/OVAL BALLOON DISSECTOR

    MDR report key: 3960956 · Received May 23, 2014

    Report

    Report Number
    2647580-2014-00380
    Event Type
    Malfunction
    Date Received
    May 23, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT SENT: MAY 23, 2014.

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUENAL HERNIA REPAIR. ACCORDING TO THE REPORTER: DOES NOT SEAL WHEN THE SCOPE IS TAKEN OUT. OPENED ANOTHER ONE. NO OTHER INFORMATION AVAILABLE FROM MATERIALS. PACKAGING WAS DISCARDED SO LOT NUMBER IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309323 SM PLUS BTT/OVAL BALLOON DISSECTOR SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC NA

    Patients

    Seq Age Sex Outcome Treatment
    1