BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 1903807 · Received November 20, 2010

    Report

    Report Number
    3005992282-2010-00371
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    April 22, 2010
    Report Date
    November 5, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAND/BALLOON WITH 20 CM OF CATHETER WAS RETURNED FOR ANALYSIS. EVALUATION OF THE DEVICE CANNOT CONFIRM EVENTS THAT ARE PHYSIOLOGICAL IN NATURE. EROSION IS A RECOGNIZED ADVERSE EVENT ASSOCIATED WITH GASTRIC BANDING AND THE SWEDISH ADJUSTABLE GASTRIC BAND. A REVIEW OF THE MANUFACTURING RECORDS 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

    ON (B)(6), 2010 A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO TL IMPLANT THREE (3) MONTHS AFTER PLACEMENT DUE TO NON-OSSEOINTEGRATION AND TO A LOCALIZED INFECTION. THIS IS THE FIRST OF THREE REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT OF A (B)(4) ADJUSTABLE GASTRIC BAND A GASTRIC EROSION WAS OBSERVED AND THAT BAND WAS REMOVED WITH NO REPORTED PATIENT COMPLICATIONS. ADDITIONAL FOLLOW UP IS BEING CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICK CLOSE IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK 0404002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention