BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 1981446 · Received January 11, 2011

    Report

    Report Number
    2647580-2011-00030
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 16, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT CAME IN A MEDWATCH FORM, HOWEVER THERE IS NO REPORT NUMBER ON THE FORM. IT IS UNCLEAR IF THE MEDWATCH WAS ACTUALLY FILED WITH THE FDA.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: SURGEON USING A (B)(4) DISTENTION BALLOON DURING A SURGICAL PROCEDURE ON A PATIENT WHEN THE BALLOON RUPTURED. SURGEON RETRIEVED THE PIECE OF BALLOON FROM THE CAVITY. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER PREPERITONEAL DIST BALLOON DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0B0856

    Patients

    Seq Age Sex Outcome Treatment
    1