BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1822414 · Received September 1, 2010

    Report

    Report Number
    3005992282-2010-00258
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    October 23, 2009
    Report Date
    August 4, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A REALIZE ADJUSTABLE BAND, THE PATIENT WAS EXPERIENCING NO RESTRICTION. DURING A ROUTINE FILL, THEY WERE NOT ABLE TO EXTRACT ANY FLUID. A LEAK WAS DETECTED AT THE PORT. ON (B)(4), 2009 THE PORT WAS REMOVED AND A NEW ONE WAS IMPLANTED. THERE WAS NO REPORTED PATIENT COMPLICATIONS.

    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 ZKBBL1

    Patients

    Seq Age Sex Outcome Treatment
    1