BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 3893522 · Received February 14, 2014

    Report

    Report Number
    2647580-2014-00088
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 23, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K946002
    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: OMSPDBS2 WAS INSERTED, INFLATED AND DEFLATED PROPERLY. DURING REMOVAL FROM THE PT, THE BALLOON DETACHED FROM THE PORT AND THEN HAD TO BE REMOVED SEPARATELY. DR (B)(6) SPOKE TO ME (B)(6) 2014 AND HAS STATED IT WASN'T A PROBLEM BUT THOUGHT WE SHOULD KNOW. THEY SAVED THE SOILED BALLOON AND PORT WHICH I AM RETURNING. PT OUTCOME: NIL ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99193 SPACEMAKER PREPERITONEAL DIST BALLOON SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC P3J069X

    Patients

    Seq Age Sex Outcome Treatment
    1