BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 1811621 · Received August 23, 2010

    Report

    Report Number
    3005992282-2010-00246
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 29, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SWEDISH ADJUSTABLE BAND WAS REPLACED BECAUSE THE PATIENT WAS NOT GETTING RESTRICTION. DURING THE REPLACEMENT PROCEDURE, THE BUCKLE WAS NOTED TO BE TORN. NO FURTHER INFORMATION IS AVAILABLE INCLUDING THE DATE OF THE INITIAL SURGERY TO IMPLANT THE BAND. FACILITY IS UNWILLING TO PROVIDE INFORMATION. THE PATIENT STATUS IS STABLE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1