BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AP LG, ACCESS PORT KIT RAPIDPORT EZ

    MDR report key: 2810030 · Received October 23, 2012

    Report

    Report Number
    2024601-2012-01089
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    August 18, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER DISCARDED THE DEVICE WHEN IT WAS EXPLANTED AND IT IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, ALLERGAN WILL NOT RECEIVE IT AND NO ANALYSIS OR TESTING WILL BE DONE. DYSPHAGIA IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A LAP-BAND PORT EXPLANT WITHOUT REPLACEMENT. THE PT PRESENTED TO THE HOSPITAL REPORTING NOT BEING ABLE TO "TAKE DOWN LIQUIDS." THE EXPLANTED BAND ASSOCIATED WITH THIS RECORD IS BEING DOCUMENTED IN MEDWATCH REPORT # 2024601-2012-01087.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AP LG, ACCESS PORT KIT RAPIDPORT EZ LTI ALLERGAN NA 2185429

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention PRILOSEC| XANAX| XANTAC| AXERT| LORTAB