BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 2133979 · Received June 20, 2011

    Report

    Report Number
    3005992282-2011-00144
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 30, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED. POUCH DILATATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT THE PATIENT ENROLLED IN THE (B)(6) REGISTRY HAD HAD AN ESOPHAGEAL DILATATION. THE SURGEON REMOVED THE BAND DUE TO ESOPHAGEAL DILATATION. ONLY ONE FILLING OF 5.5CC WAS PERFORMED ON (B)(6) 2008. THE PATIENT HAS LOST 17KG SINCE THE SURGERY. ADDITIONAL FOLLOW UP IS BEING CONDUCTED. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.

    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 ZHDBF6

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention