BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 5302838 · Received September 14, 2004

    Report

    Report Number
    2024601-2004-00548
    Event Type
    Malfunction
    Date Received
    September 14, 2004
    Date of Event
    August 19, 2004
    Report Date
    August 19, 2004
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER I. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER I. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAM MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT.

    Description of Event or Problem · 1

    PT REPORTED AS "BROKEN PORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBIN OBESITY LTI BIOENTERICS CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other