BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    MDR report key: 3841160 · Received February 26, 2014

    Report

    Report Number
    2647580-2014-00117
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP INGUINAL HERNIA. ACCORDING TO THE RPTR: DR PLACED STRUCTURAL BALLOON TROCAR IN PT BUT COULD NOT GET IT TO INFLATE WITH THE BULB PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117665 SPACEMAKER STRUCTURAL BALLOON TROCAR SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC P3F0633X

    Patients

    Seq Age Sex Outcome Treatment
    1