BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 4121270 · Received September 22, 2014

    Report

    Report Number
    2024601-2014-00552
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    February 1, 2010
    Report Date
    September 4, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONTACT INFO WAS PROVIDED FOR THE REPORTER OF THE COMPLAINT. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. BAND SLIPPAGE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    REPORTED EVENT OF BAND MIGRATION OF LAP-BAND (R) DEVICE WITHIN THREE PATIENTS FROM JOURNAL ABSTRACT, "TREATMENT STRATEGY OF BAND MIGRATION," OBES SURG (2014) 24:1136-1378.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587803 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention