BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS BTT/ROUND BALLOON DISSECTOR

    MDR report key: 2890609 · Received November 21, 2012

    Report

    Report Number
    2647580-2012-00733
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DIDN'T INFLATE PROPERLY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250 CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS BTT/ROUND BALLOON DISSECTOR SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P2AA0326

    Patients

    Seq Age Sex Outcome Treatment
    1