BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITIONAL DIST BALLOON

    MDR report key: 3080697 · Received April 9, 2013

    Report

    Report Number
    2647580-2013-00192
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GEX
    PMA / PMN Number
    K946002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: DR (B)(6) DID AN INITIAL INFLATION AND THE BALLOON POPPED. A SECOND DEVICE WAS OPENED INSERTED AND THE CASE PROCEEDED WITH NO OTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147967 SPACEMAKER PREPERITIONAL DIST BALLOON SPACEMAKER BALLOONS GEX COVIDIEN, FORMERLY USSC P3A0176X

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR