BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER EXTRA VIEW BALLOON - OVAL

    MDR report key: 1905735 · Received November 16, 2010

    Report

    Report Number
    2647580-2010-00908
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 20, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K954175
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO EVALUATION OF THE ACTUAL DEVICE, BECAUSE IT WAS THROWN AWAY. WE ONLY RECEIVED THE LABEL FOR THIS DEVICE.

    Description of Event or Problem · 1

    PROCEDURE TYPE: TEP HERNIA. PT GENDER: UNKNOWN. ACCORDING TO THE REPORTER: THIS PRODUCT IS USED ROUTINELY. THE BALLOON BURST WHEN USING THE PUMP AND LEFT BALLOON INSIDE THE PT. THERE IS NO PRODUCT TO SEND AS WAS THROWN BLOOD LOSS AND LESS THAN 30 MINUTES ADDED TO PROCEDURE. PT STATUS: FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER EXTRA VIEW BALLOON - OVAL DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0E0802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other