BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 3040130 · Received April 3, 2013

    Report

    Report Number
    2024601-2013-00203
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 28, 2010
    Report Date
    June 27, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT REMAINS IMPLANTED 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. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. VOMIT IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF VOMIT AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PATIENT EATS MORE THAN RECOMMENDED."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED VOMITING. ACTION TAKEN WAS AN ADJUSTMENT AND SURGICAL REVISION SPECIFIED AS "UNLOCKING" OF THE LAP-BAND AP SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136300 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1773216

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention