BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1843050 · Received September 23, 2010

    Report

    Report Number
    3005992282-2010-00284
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 21, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A REALIZE GASTRIC BAND, THE PATIENT REPORTED LACK OF RESTRICTION DURING A ROUTINE FILL. IT WAS DETERMINED THROUGH A DIAGNOSTIC LAPAROSCOPY THE PORT DISCONNECTED. THE PORT WAS REPLACED WITHOUT ANY IMPACT TO THE PATIENT. THE SURGEON REPORTS PUTTING THE TUBING A LITTLE PASSED THE LIP. THE LOCKING CONNECTOR AND STRAIN RELIEF WERE STILL ATTACHED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1