BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1931237 · Received December 17, 2010

    Report

    Report Number
    3005992282-2010-00450
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 16, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-IMPLANT A REALIZE ADJUSTABLE BAND, THE PATIENT HAD FOUR FILLS. THE FILL DATES WERE (B)(6) 2009, (B)(6) 2010. THE AMOUNTS OF EACH FILL IS UNKNOWN. THE PATIENT WAS NOT LOSING WEIGHT; HAD LITTLE RESTRICTION AND THE SURGEON HAD NO FEEDBACK DURING THE FILLS. ON (B)(6) 2010, THE FILL WAS ADMINISTERED UNDER FLUOROSCOPY. THE SURGEON SUSPECTED THERE WAS A LEAK OR THE TUBING HAD DISCONNECTED FROM THE PORT. DURING SURGERY ON (B)(6) 2010, IT WAS CONFIRMED THE TUBING HAD BECOME DISCONNECTED FROM THE PORT. THE LOCKING CONNECTOR WAS STILL ATTACHED TO THE PORT IN THE LOCKED POSITION. THE STRAIN RELIEF WAS FREE INSIDE OF PATIENT, NOT ON TUBING. IT WAS NOT RETRIEVED. THE PORT WAS REPLACED; THE TUBING WAS CONNECTED TO THE NEW PORT. THE NEW PORT WAS LOCKED AND UNLOCKED AND LOCKED AGAIN. EXAMINED THE TUBING TO MAKE SURE IT WAS STAYING IN PLACE. THE ORIGINAL PORT WAS DISCARDED. THE PATIENT IS OKAY.

    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