BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 3070960 · Received April 1, 2013

    Report

    Report Number
    2647580-2013-00181
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 5, 2013
    Manufacturer
    COVIDIEN, FORMELRY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: IGUENAL HERNIA REPAIR ACCORDING TO THE REPORTER: DURING PROCEDURE, THE BALLOON RUPTURED AFTER PUMPING THREE TIMES. NEW DEVICE WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133123 SPACEMAKER PREPERITONEAL DIST BALLOON SPACEMAKER BALLONS GCJ COVIDIEN, FORMELRY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1