BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 4093128 · Received September 10, 2014

    Report

    Report Number
    2647580-2014-00760
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Report Date
    August 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K946002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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: SURGEON STATED BAG WOULD NOT DEPLOY. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMGE. THERE WAS NO UNANTICIPATED EXTENSION FOR THE INCISION MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS NO DELAY OVER 30 MINS. NO DEVICE FRAGMENT FELL IN THE PT CAVITY. NO DEVICE FRAGMENT WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559645 SPACEMAKER PREPERITONEAL DIST BALLOON SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P4C0726X

    Patients

    Seq Age Sex Outcome Treatment
    1