BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    MDR report key: 3982497 · Received June 23, 2014

    Report

    Report Number
    2647580-2014-00470
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4). DATE OF INITIAL REPORT SENT: (B)(4) 2014.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP INGUINAL HERNIA. ACCORDING TO THE REPORTER: BALLOON WOULD NOT INFLATE. INSUFFLATION VALVE NOT FUNCTIONING. APPLIED ANOTHER DEVICE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 250CC. THERE WAS NO DELAY OVER 30 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367053 SPACEMAKER STRUCTURAL BALLOON TROCAR SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1