BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS BTT/OVAL BALLOON DISSECTOR

    MDR report key: 3800275 · Received May 2, 2014

    Report

    Report Number
    2647580-2014-00332
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 7, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: BALLOON WOULDN'T INFLATE. CONVERTED TO OPEN TO FINISH SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263997 SM PLUS BTT/OVAL BALLOON DISSECTOR SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other