BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 1811148 · Received August 13, 2010

    Report

    Report Number
    2647580-2010-00702
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 15, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K946002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: THE BALLOON CAME OFF THE TIP, HOWEVER, IT WAS RECOVERED AND REMOVED FROM THE PATIENT CAVITY. NO PATIENT INJURY WAS REPORTED. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER PREPERITONEAL DIST BALLOON DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0D1119

    Patients

    Seq Age Sex Outcome Treatment
    1