BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE LAP-BAND

    MDR report key: 2032216 · Received February 4, 2011

    Report

    Report Number
    2032216
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    September 10, 2010
    Report Date
    February 4, 2011
    Manufacturer
    ETHICON
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A MALFUNCTION OF THE GASTRIC BAND. THERE WAS POSTOPERTIVE LEAKAGE FROM THE GASTRIC TUBING AND PORT. THE PT HAD LAPAROSCOPIC REVISION OF THE GASTRIC BAND AND REPLACEMENT OF BAND AND PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE LAP-BAND GASTRIC BAND LTI ETHICON * ZKFBCV

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR