BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1160492 · Received September 15, 2008

    Report

    Report Number
    3005992282-2008-00154
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 19, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL WEEKS FOLLOWING A LAP GASTRIC BAND CASE, THERE WAS A KINK IN THE TUBING. UPON REPLACING THE PORT, IT WAS FOUND THAT THE SILICONE PIECE ON THE CONNECTING TUBE HAD SLID OFF AND WAS FLOATING FREELY ON THE TUBING. THE KINK WAS EXACTLY WHERE THE SILICONE REINFORCEMENT WAS SUPPOSED TO BE. THE PATIENT'S CONDITION IS UNKNOWN.

    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