BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1931189 · Received November 11, 2010

    Report

    Report Number
    2024601-2010-00899
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STRAIN RELIEF. MEDWATCH SENT TO FDA ON: (B)(4) 2010. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE SIZE, SERIAL NUMBER AND IMPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE REPORTER DID INDICATE THE STYLE OF CONNECTOR ON THE PRODUCT FIELD NOTE AS A STRAIN RELIEF. ALLERGAN HAS ALSO BEEN INFORMED THAT THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, SO THE CONNECTOR TYPE CANNOT BE CONFIRMED BY VISUAL EXAMINATION. THE REPORTER WILL NOT RETURN THE DEVICE TO ALLERGAN. THEREFORE, ALLERGAN WILL NOT RECEIVE IT AND NO ANALYSIS OR TESTING WILL BE DONE. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SIZE, SERIAL NUMBER OR THE IMPLANT DATE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AS "LEAKAGE JUNCTION TUBING OF THE ACCESS PORT." F/U FINDINGS: THE ACCESS PORT WAS REMOVED AND REPLACED. THE EXPLANTED DEVICE IS NOT BEING RETURNED FOR ANALYSIS. THE SURGEON NOTED THE CONNECTOR TYPE AS A STRAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR