BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    MDR report key: 1193181 · Received October 7, 2008

    Report

    Report Number
    2647580-2008-00584
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 23, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE BALLOON BROKE DURING INFLATION. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER STRUCTURAL BALLOON TROCAR DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P8G0288

    Patients

    Seq Age Sex Outcome Treatment
    1