BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS BTT/OVAL BALLOON DISSECTOR

    MDR report key: 3960965 · Received May 23, 2014

    Report

    Report Number
    2647580-2014-00379
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    February 27, 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).

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: IT IS MISSING A CHUNK OFF THE SEAL. NOTHING FELL INTO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED BY MATERIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309224 SM PLUS BTT/OVAL BALLOON DISSECTOR SPACEMAAKER BALLOON GCJ COVIDIEN, FORMERLY USSC P3L0326X

    Patients

    Seq Age Sex Outcome Treatment
    1