BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 4112841 · Received September 17, 2014

    Report

    Report Number
    2024601-2014-00528
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    July 4, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P00008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE 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. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. THE REPORTED EVENTS ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS, AND AN ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFO FROM THE REPORTER REGARDING EVENT PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND FOR WHICH THE PT EXPERIENCED "HEMATEMESIS" AND "A HISTORY OF PREVIOUS COMPLICATIONS," FIRST NOTICED WHEN THE PT PRESENTED WITH "HEMATEMESIS". THE HEALTHCARE PROFESSIONAL ALSO REPORTED PT WAS FOUND TO HAVE A SLIPPED LAPAROSCOPIC ADJUSTABLE GASTRIC BAND PLACEMENT". THE LAP-BAND SYSTEM WAS EXPLANTED, IT IS NOT KNOWN IT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577045 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention