BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1914300 · Received December 3, 2010

    Report

    Report Number
    3005992282-2010-00390
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER STATING THAT THE BAND WAS REMOVED AND HE HAD THE GASTRIC SLEEVE PROCEDURE. UPON REMOVAL OF THE BAND, THE SURGEON OBSERVED A LEAK IN THE BALLOON PORTION OF THE BAND. THE PATIENT STATES THE BAND WORKED FINE UNTIL 2009 AND HE WAS LOSING WEIGHT. HE IS DOING WELL AND HAPPY WITH THE NEW PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT POST OP OF A LAPAROSCOPIC GASTRIC BAND PROCEDURE THE PATIENT HAS HAD MULTIPLE FILLS AND NOW HAS OPTED TO HAVE THE BAND REMOVED AND A GASTRIC SLEEVE PROCEDURE. THE PATIENT RETURNED TO THE SURGEON IN (B)(6) 2009 DUE TO NO WEIGHT LOSS AND A WEIGHT GAIN OF 50 POUNDS; THE SURGEON THEN ADDED 6 CC'S OF FLUID, A WEEK LATER THE BAND HAD 2 CC'S. THE SURGEON THE ADDED 3 CC'S; A WEEK LATER IT WAS BACK TO 2 CC'S AGAIN. THE SURGEON PERFORMED AN X-RAY AND ATTEMPTED TO ADD FLUID; HIS BAND WOULD NOT ACCEPT THE FLUID THROUGH THE PORT OR ALLOW HIM TO REMOVE ANY FLUID. PATIENT IS DOING WELL AT THIS TIME.

    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 34 YR