BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    MDR report key: 3850750 · Received March 20, 2014

    Report

    Report Number
    2647580-2014-00197
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 26, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: BALLOON WAS INSERTED INTO PATIENT, ATTEMPT MADE TO INFLATE THE BALLOON, HOWEVER, IT WOULD NOT INFLATE. BALLOON WAS REMOVED AND A SECOND PLACED, NO ISSUES WITH SECOND ATTEMPT. PATIENT OUTCOME: NIL ADVERSE PATIENT OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166757 SPACEMAKER STRUCTURAL BALLOON TROCAR SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC NA

    Patients

    Seq Age Sex Outcome Treatment
    1