BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1972978 · Received January 28, 2011

    Report

    Report Number
    3005992282-2011-00022
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    April 1, 2008
    Report Date
    January 4, 2011
    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). CORRECTED DATA = YEAR SHOULD HAVE BEEN 2011.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED. DEVICE REMAINS IMPLANTED.(B)(4)

    Description of Event or Problem · 1

    SPOKE WITH THE PATIENT ON (B)(6), 2011 AND SHE STATES THAT THERE HAS NOT BEEN ANY ISSUE ACCESSING THE PORT ON HER LAST TWO FILLS. SHE FEELS THE BAND HAD BEEN FAIRLY SUCCESSFUL AND OVERALL HAPPY WITH RESULTS. STATES SHE WILL CONTACT THE COMPANY IF PORT DISLOCATION BECOMES A PROBLEM WITH FILLS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1