BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS BTT/ROUND BALLOON DISSECTOR

    MDR report key: 3190611 · Received June 13, 2013

    Report

    Report Number
    2647580-2013-00318
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 17, 2013
    Manufacturer
    COVIDIEN FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: A RUBBER GASKET SEAL BECAME DISPLACED ONTO THE OBTURATOR AND CAME OUT ONTO BALLOON PORTION OF THE OBTURATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269898 SM PLUS BTT/ROUND BALLOON DISSECTOR SPACE MAKER BALLOON GCJ COVIDIEN FORMERLY USSC PUERTO RICO P2K0372X

    Patients

    Seq Age Sex Outcome Treatment
    1