BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACERMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 2010760 · Received January 7, 2010

    Report

    Report Number
    2647580-2011-00025
    Event Type
    Malfunction
    Date Received
    January 7, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 10, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GEX
    PMA / PMN Number
    K946002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACCOUNT SENT A COPY OF A HANDWRITTEN MEDWATCH WITH THIS REPORT NUMBER WRITTEN ON THE TOP OF THE FORM: (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP HERNIA REPAIR. PT GENDER: UNK. ACCORDING TO THE REPORTER: INTRA-OPERATIVE DEVICE FAILURE. THE DISTENTION BALLOON BROKE INTO 2 PARTS INSIDE PT WHILE DISTENDING SPACE. PIECES RETRIEVED LAPAROSCOPICALLY. NO PT INJURY WAS REPORTED. NO ADD'L INFO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACERMAKER PREPERITONEAL DIST BALLOON DISPOSABLE SURGICAL ACCESS DEVICE GEX USSC PUERTO RICO P9E0069

    Patients

    Seq Age Sex Outcome Treatment
    1