BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1250790 · Received December 2, 2008

    Report

    Report Number
    3005992282-2008-00229
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    August 15, 2008
    Report Date
    November 21, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ADJUSTABLE BAND PROCEDURE, THE BALLOON WAS PUNCTURED DURING PLACEMENT. A NEW BAND WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND STR LTI IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1