BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEDISH ADJUSTABLE GASTRIC BAND

    MDR report key: 1872936 · Received October 18, 2010

    Report

    Report Number
    3005992282-2010-00318
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 22, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK ON FOLDLINE THE BAND/BALLOON WITH 19CM OF CATHETER AND A PIECE OF CATHETER 24.5CM IN LENGTH WAS RETURNED FOR ANALYSIS. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT A BLUE COLOR WAS INSIDE OF THE BALLOON AND THE CATHETER. FOUR (4) FOLD LINES WERE ON THE BALLOON, LOCALIZED NEAR THE CATHETER CONNECTION. NO PUNCTURE WAS FOUND ON THE BALLOON DURING THE VISUAL INSPECTION. A FUNCTIONAL TEST WAS PERFORMED ON THE BALLOON WITH AN UNSUCCESSFUL RESULT, A LEAKAGE WAS FOUND. UNDER MICROSCOPE IT WAS OBSERVED THAT A VERY SMALL PUNCTURE WAS FOUND ON ONE FOLD LINE. THE PUNCTURE IS SMALLER THAN 0.1MM AND CANNOT BE MEASURED BY CALIPER.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A MICRO LEAKAGE WAS DETECT IN THE BAND POST IMPLANT A (B)(4) ADJUSTABLE GASTRIC BAND. THIS LEAKAGE WAS DETECTED BY BLUE TEST AND AIR INJECTION, THE BAND WAS EXPLANTED AND ANOTHER BAND WAS PLACED. THE PATIENT IS FINE .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEDISH ADJUSTABLE GASTRIC BAND IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK 990344

    Patients

    Seq Age Sex Outcome Treatment
    1