BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE GASTRIC BAND

    MDR report key: 1980129 · Received January 20, 2011

    Report

    Report Number
    1980129
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ETHICON
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THE REALIZE BAND CUFF MIGRATION WAS DISCOVERED DURING A SURGICAL PROCEDURE TO REMOVE THE GASTRIC BAND. IT WAS RELATED TO THE SLIPPAGE OF THE BAND THAT CAUSED COMPLICATIONS AND WAS UNRELATED TO THE CUFF MIGRATION. THE ETHICON ENDO-SURGERY RECENTLY NOTIFIED THE FACILITY OF A VOLUNTARY RECALL OF THE REALIZE ADJUSTABLE GASTRIC BAND RELATED TO CUFF/SHEATH MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE GASTRIC BAND REALIZE ADJUSTABLE GASTRIC BAND LTI ETHICON RLZB22 ZJJBF9

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR