BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 1193185 · Received October 7, 2008

    Report

    Report Number
    2647580-2008-00586
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: NEPHRECTOMY. ACCORDING TO THE REPORTER: THE BALLOON BROKE PRIOR TO USE. USED ANOTHER. NO BLEEDING. NO TISSUE DAMAGE. NOTHING FELL INTO CAVITY. PATIENT STATUS: OK, NO OTHER PATIENT INFO AVAILABLE. EXTENDED OR TIME: UNKNOWN. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1