BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 1081094 · Received July 21, 2008

    Report

    Report Number
    3005992282-2008-00109
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 1, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PLACEMENT OF THE INJECTION PORT OF THE BAND DURING A LAP ADJUSTABLE BAND PROCEDURE, THE TUBING STRAIN RELIEF DISCONNECTED FROM THE LOCKING CONNECTOR. THE TUBING STRAIN RELIEF WAS LOOSE AND EASILY DETACHED. THE SURGEON RECONNECTED THE TUBING STRAIN RELIEF EACH TIME ON SEVERAL OCCASIONS. THE DEVICE IS STILL IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1