BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1241031 · Received November 21, 2008

    Report

    Report Number
    3005992282-2008-00219
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    July 10, 2008
    Report Date
    October 30, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/21/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OP OF A LAP ADJUSTABLE BAND PROCEDURE, THE TUBING BECAME KINKED AT THE DISTAL END OF THE STRAIN RELIEF. THIS WAS CAUSED BY THE PLASTIC COVERING OF THE CONNECTOR WHEN IT MIGRATED DOWN AND KINKED THE TUBING. ANOTHER DEVICE WAS OPENED FOR THE REOPERATION TO COMPLETE THE PROCEDURE. THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND STR LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention