BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICKCLOSE WITH VELOCITY INJECTION PORT

    MDR report key: 1012589 · Received March 12, 2008

    Report

    Report Number
    3005992282-2008-00035
    Event Type
    Injury
    Date Received
    March 12, 2008
    Report Date
    February 19, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMAITON NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE WEEKS AFTER A GASTRIC BAND WAS IMPLANTED, THERE WAS AN ALLEGED PORT REACTION WHICH CAUSED INFLAMMATION AND THEN INFECTION. THE DEVICE WAS EXPLANTED AND REPLACED WITH A LAP BAND FROM A COMPETITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R