BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 387154 · Received April 4, 2002

    Report

    Report Number
    2028368-2002-00183
    Event Type
    Malfunction
    Date Received
    April 4, 2002
    Date of Event
    March 9, 2002
    Report Date
    March 9, 2002
    Manufacturer
    BIOENTERICS CORP.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN FILING THE SYSTEM BAND, NO SALINE COULD BE WITHDRAWN. EXACT CAUSE NOT KNOWN AT THE TIME. F/U FINDINGS 03/2002: REPORTED BY THE DOCTOR'S NURSE TO THE SALES REP: THE X-RAY SHOWS THAT THE PORT WAS SEPARATED FROM THE TUBING. HE IS TAKING THE PATIENT TO SURGERY TO FIX IT. THE NURSE DID NOT KNOW WHEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other