BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1893487 · Received November 8, 2010

    Report

    Report Number
    3005992282-2010-00354
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). BIOLOGICAL DEBRIS IMPEDED PORT FUNCTION. THE VELOCITY PORT AND THE LOCKING CONNECTOR WERE RETURNED FOR ANALYSIS. VISUAL/FUNCTIONAL COMMENTS: PUNCTURES WERE OBSERVED AT THE BACK OF THE PORT AT THE ETCHED LOT NUMBER AREA. THE PORT WAS RETURNED WITH HOOKS RETRACTED AND THE ACTUATOR RING IN UNLOCKED POSITION. THE LOCKING CONNECTOR WAS LOCKED CORRECTLY. THE TUBING STRAIN RELIEF WAS NOT RETURNED. BIOLOGICAL DEBRIS WAS OBSERVED IN THE PORT MECHANISM. PORT MECHANISM WAS OBSERVED TO BE BLOCKED. HOOKS COULD NOT BE DEPLOYED WITH THE USE OF A SAMPLE APPLIER AND MANUALLY. THE PORT WAS DISMANTLED AND BIOLOGICAL DEBRIS WAS BLOCKING THE PORT MECHANISM. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A REALIZE ADJUSTABLE BAND, THE PORT WAS NOTED TO HAVE FLIPPED ON (B)(6) 2010. THE PORT WAS REPLACED ON (B)(6) 2010 WITH REPORTED PATIENT CONSEQUENCE.

    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 ZKNBDG

    Patients

    Seq Age Sex Outcome Treatment
    1