BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 1071872 · Received July 9, 2008

    Report

    Report Number
    3005992282-2008-00100
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 12, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BANDING PROCEDURE, WHEN THEY WERE TESTING THE BAND, THERE WAS A LEAK ON THE BALLOON. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA LTI OBTECH MEDICAL SARL NA 20052462

    Patients

    Seq Age Sex Outcome Treatment
    1