BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICKCLOSE WITH VELOCITY INJECTION PORT

    MDR report key: 1000977 · Received February 19, 2008

    Report

    Report Number
    3005992282-2008-00010
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    November 13, 2007
    Report Date
    January 29, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 02/19/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LAP ADJUSTABLE BAND PROCEDURE, THE PATIENT DEVELOPED AN ACUTE GASTRIC EROSION (PERIGASTRIC & HEPATIC) WHICH NECESSITATED REMOVAL OF THE BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICKCLOSE WITH VELOCITY INJECTION PORT LTI LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention