BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 1405894 · Received June 19, 2009

    Report

    Report Number
    3005992282-2009-00179
    Event Type
    Injury
    Date Received
    June 19, 2009
    Date of Event
    February 6, 2009
    Report Date
    June 16, 2009
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 6/19/2009. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALLEGED BAND PERFORATION OCCURRED POST-OP ADJUSTABLE GASTRIC BAND PROCEDURE. THE FILLING OF THE BAND HAS NEVER BEEN EFFECTIVE. THE SURGEON DECIDED TO CHANGE THE BAND. DURING THE PROCEDURE, IT APPEARED THAT THE BAND WAS FOUND TO BE PERFORATED. THE BAND WAS REMOVED AND REPLACED BY A NEW ONE WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICK CLOSE LTI OBTECH MEDICAL SARL NA ZHGBBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention