BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1111067 · Received August 13, 2008

    Report

    Report Number
    3005992282-2008-00134
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 25, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 8/13/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED THE LAP BAND IN 2008. THREE MONTHS POST OP, THE PT WENT TO THE PRIMARY CARE PHYSICIAN WITH PAIN IN THE RIGHT LOWER QUADRANT. A CT SCAN WAS PERFORMED AND THE TUBING WAS FOUND TO BE DISCONNECTED FROM THE PORT. THE RE-OPERATION WAS PERFORMED. THE PORT WAS STILL IN PLACE AND THE SILVER LOCKING CONNECTOR WAS STILL LOCKED ONTO THE PORT. THE PORT WAS REMOVED AND REPLACED WITH A NEW ONE. THE TUBING PROTECTION SLEEVE HAD BECOME DISCONNECTED FROM THE LOCKING CONNECTOR AND WAS FREE FLOATING FROM THE TUBING. THE TUBING WAS FOUND IN A LOWER HALF OF THE BODY. THE PT IS OKAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention