BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDINGSYSTEM 10.0CM

    MDR report key: 4101616 · Received August 27, 2014

    Report

    Report Number
    2024601-2014-00448
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    June 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

    TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. POUCH DILATION, REFLUX AND HEARTBURN 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 PT SEEN FOR HEARTBURN AND REFLUX++. BARIUM SWALLOW - LARGE POUCH SEEN - FOR BAND REPLACEMENT. THE 10CM BAND WAS EXCHANGED FOR AN APL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522668 LAP-BAND ADJUSTABLE GASTRIC BANDINGSYSTEM 10.0CM LTI ALLERGAN NA 1272361

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention NONE PER FACILITY