BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 2760218 · Received September 20, 2012

    Report

    Report Number
    2647580-2012-00604
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    August 17, 2012
    Report Date
    August 23, 2012
    Manufacturer
    COVIDEN, FORMERLY USSC
    Product Code
    GEX
    PMA / PMN Number
    K946002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE BALLOON WAS INSERTED IN THE PT. WHILE INSIDE THE CAVITY, THE BALLOON CAME OFF. THE ENTIRE BALLOON WAS REMOVED LAPAROSCOPICALLY FROM THE PT'S CAVITY. THE PROCEDURE WAS THEN CONVERTED TO AN OPEN CASE. IT COULD NOT BE REPORTED IF THE CASE WAS DELAYED MORE THAN 30 MINUTES. IT COULD NOT BE REPORTED IF BLOOD LOSS OCCURRED OR IF TISSUE DAMAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER PREPERITONEAL DIST BALLOON SPACEMAKER BALLOON GEX COVIDEN, FORMERLY USSC P1F0028

    Patients

    Seq Age Sex Outcome Treatment
    1