BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1071879 · Received July 9, 2008

    Report

    Report Number
    3005992282-2008-00103
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Report Date
    June 16, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP OF A LAP GASTRIC BAND PROCEDURE, THE TUBING STRAIN RELEASE BECAME DISCONNECTED FROM THE CONNECTOR TUBE. THE STRAIN RELEASE WAS FLOATING ALONG SIDE THE TUBING, AND COULD NOT PREVENT THE TUBING FROM KINKING. THIS WAS NOTICED DURING A FILL OF THE DEVICE.

    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