BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

    MDR report key: 4230591 · Received November 6, 2014

    Report

    Report Number
    3005992282-2014-00061
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    June 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE BAND WAS RECEIVED CUT INTO, WITH 16 CM OF CATHETER ATTACHED. THE CUT WAS MADE NEAR THE CLOSED END OF THE BAND. SOME BIO DEBRIS WAS EVIDENT. NO OTHER PUNCTURES OR TEARS WERE VISIBLE. THE PORT WAS RECEIVED WITH 7 CM OF CATHETER ATTACHED. BIO DEBRIS WAS EVIDENT IN AND AROUND THE PORT. THE ACTUATOR RING WAS IN LOCKED POSITION AND COULD NOT BE MOVED MANUALLY. THE COMPLAINT OF BAND SLIPPAGE CANNOT BE CONFIRMED AS PRODUCT ANALYSIS CANNOT CONFIRM EVENTS THAT ARE PHYSIOLOGICAL IN NATURE. WHILE IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING ROOT CAUSE OF BAND SLIPPAGE, IT IS NOTED THAT BAND SLIPPAGE IS A RECOGNIZED ADVERSE EVENT ASSOCIATED WITH GASTRIC BANDING AND THE USE OF THE REALIZE ADJUSTABLE GASTRIC BAND. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO DISCREPANCIES WERE NOTED ON THE FILE DURING THE MANUFACTURING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714588 IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR