BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2080376 · Received May 6, 2011

    Report

    Report Number
    3005992282-2011-00106
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 12, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): BUCKLE TORN. THE BAND/BALLOON WITH ONE-WAY VALVE WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THE BUCKLE WAS DAMAGED. A TEAR WAS OBSERVED ON THE OPPOSITE SIDE OF THE SNORKEL (STRAIN RELIEF). SALINE WATER (3ML) WAS OBSERVED INSIDE OF THE BALLOON. A LEAK TEST WAS PERFORMED ON THE BALLOON WITH A SUCCESSFUL RESULT, NO LEAK WAS FOUND. THE COMPLAINT WAS CONFIRMED, BUCKLE WAS RETURNED DAMAGED ON ONE SIDE AND SALINE SOLUTION (3ML) WAS FOUND INSIDE OF THE BALLOON. A POTENTIAL CAUSE OF THE REPORTED EVENT IS THAT THE DAMAGE MAY BE THE RESULT OF MANIPULATION DURING IMPLANTATION, THIS IS CONFIRMED BY THE FACT THAT SALINE WATER WAS FOUND INSIDE OF THE BALLOON. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS, A REVIEW OF THE MANUFACTURING PROCESS WAS ALSO PERFORMED AND IT WAS NOTED THAT 100% BAND/BALLOON ARE VISUAL INSPECTED PRIOR RELEASE, THEREFORE IT IS UNLIKELY THAT A MANUFACTURING ISSUE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REALIZE BAND PROCEDURE, THE FEMALE PORTION OF THE BUCKLE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER BAND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1