BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2945468 · Received February 6, 2013

    Report

    Report Number
    3005992282-2013-00011
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    September 1, 2012
    Report Date
    January 11, 2013
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CONSUMER THAT POST IMPLANT A REALIZE BAND, THE BAND IS NOT RETAINING THE FILL VOLUME. EACH ADJUSTMENT WAS 1-2CCS. IN (B)(6) 2012 THE PATIENT STATES THAT SHE LACKED RESTRICTION. DUE TO THE CHANGE IN INSURANCE COMPANIES, THE PATIENT HAD TO LOCATE A NEW DOCTOR. IN (B)(6) 20112 ALL OF THE FLUID WAS REMOVED AND 2CCS WERE ADDED. THE SURGEON NOTED THE FLUID WAS YELLOW IN COLOR, COMMENTED THAT IT WAS BODY FLUID AND DETERMINED THE BAND WAS BROKEN. THE CONSUMER IS CURRENTLY WAITING APPROVAL FROM INSURANCE COMPANY TO HAVE THE BAND REPLACED. THE BAND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50093 REALIZE ADJ GASTRIC BAND-C IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1