BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 1961642 · Received January 14, 2011

    Report

    Report Number
    3005992282-2011-00013
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    October 16, 2010
    Report Date
    January 12, 2011
    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 UNAVAILABLE. THE DEVICE WAS NOT RETURNED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN THE (B)(6) HAD AN ESOPHAGEAL DILATATION. THE PATIENT HAD FOOD INTOLERANCE AND VOMITING, RADIOLOGY EXAM IDENTIFIED AN ESOPHAGIAL DILATATION, BAND WAS TOO FILLED. THE BAND WAS DEFLATED (1CC).

    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 ZHGBBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention