BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 3896744 · Received May 20, 2014

    Report

    Report Number
    2647580-2014-00371
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 23, 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).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC REPAIR OF BILATERAL INGUINAL HERNIAS. ACCORDING TO THE REPORTER: SPACEMAKER DEVICE WOULD NOT INFLATE DUE TO A HOLE IN THE BALLOON. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT FELL INTO THE PT. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299566 SM PLUS SBT/OVAL BALLOON DISSECTOR SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC P3M0630X

    Patients

    Seq Age Sex Outcome Treatment
    1