BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS BTT/OVAL BALLOON DISSERCTOR

    MDR report key: 2863522 · Received November 1, 2012

    Report

    Report Number
    2647580-2012-00698
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 8, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    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: THE OVAL BALLOON BROKE OFF/BURST INSIDE THE PT'S CAVITY. ALL PIECES WERE RETRIEVED. A NEW ONE WAS OPENED FOR THE CASE. NO BLEEDING OR DELAY IN OPERATING ROOM TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS BTT/OVAL BALLOON DISSERCTOR SPACEMAKER PLUS BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P2B0209

    Patients

    Seq Age Sex Outcome Treatment
    1