BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 4172801 · Received October 10, 2014

    Report

    Report Number
    2024601-2014-00559
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. NAUSEA, VOMITING, WEIGHT FLUCTUATION, 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 A LAP-BAND SYSTEM FOR WHICH THE PT "LOST 14 LBS AND GAINED 7 BACK. EXPERIENCES NAUSEA AND VOMITING OCCASIONALLY," AND "IS FEELING FRUSTRATION" THAT "AFFECTS THE PT'S DAILY LIFE." IT IS NOT SPECIFIED HOW THE PROBLEM WAS FIRST NOTICED. THE LAP-BAND SYSTEM WAS REMOVED AND NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642592 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2204363

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention