BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT

    MDR report key: 2830557 · Received November 13, 2012

    Report

    Report Number
    3005992282-2012-00159
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 19, 2012
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAND, INJECTION PORT AND TUBING STRAIN RELIEF WAS RETURNED FOR ANALYSIS. DEVICE ANALYSIS CANNOT CONFIRM EVENTS THAT ARE PHYSIOLOGICAL IN NATURE SUCH AS "GASTRIC PROLAPSE". WHILE IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING ROOT CAUSE OF THE GASTRIC PROLAPSE, IT IS NOTED THAT GASTRIC PROLAPSE IS A RECOGNIZED ADVERSE EVENT ASSOCIATED WITH GASTRIC BANDING AND THE USE OF THE REALIZE ADJUSTABLE GASTRIC BAND. DEPENDING ON SEVERITY, THIS MAY REQUIRE BAND DEFLATION, OR A SECOND OPERATION TO REPOSITION OR REMOVE THE BAND. A DEVICE HISTORY (DHR) REVIEW WAS PERFORMED, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS IN RELATION TO THE ALLEGED ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT AN ADJUSTABLE BAND PROCEDURE, THE BAND WAS REMOVED. THE PATIENT HAD A GASTRIC PROLAPSE ABOVE THE BAND. THE SURGEON WHO EXPLANTED THE BAND DID NOT IMPLANT THE BAND. THE NUMBER OF BAND ADJUSTMENTS ARE UNKNOWN. THE IMPLANT DATE IS UNKNOWN. THE BAND WAS EXPLANTED AND THE PATIENT WAS CONVERTED TO A SLEEVE GASTRECTOMY. THE PATIENT WAS DISCHARGED HOME WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention