BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 1071870 · Received July 9, 2008

    Report

    Report Number
    3005992282-2008-00099
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 13, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A LAP ADJUSTABLE BAND PROCEDURE, A POROSITY OF THE BAND WAS OBSERVED BEFORE IMPLANTATION OF THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO PERFORM THE OPERATION. NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1