BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM ACCESS PORT II KIT

    MDR report key: 4101615 · Received August 27, 2014

    Report

    Report Number
    2024601-2014-00450
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    April 15, 2014
    Report Date
    July 31, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. SEE RELATED MEDWATCH REPORT: 2024601-2013-00063. BAND RESTRICTION ISSUES AND INTOLERANCE ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED, "HAVING DIFFICULTIES FOR A FEW MONTHS - WANTING BAND OUT. BARIUM SWALLOW - BAND TIGHT - TOTAL DEFILL. REQUESTING BAND OUT." REPLACEMENT ACCESS PORT ALSO REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522485 LAP-BAND SYSTEM ACCESS PORT II KIT LTI ALLERGAN NA 2286392

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention INSULIN INFUSION PUMP,| RAMIPRIL 5MG OD,| BISOPROLOL| METFORMIN 500MG BID,