BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 2113053 · Received June 3, 2011

    Report

    Report Number
    3005992282-2011-00125
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 6, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING COMPONENTS WERE RETURNED: THE BAND/BALLOON WITH 24CM OF CATHETER, AND THE TUBING STRAIN RELIEF; THE INJECTION PORT WITH THE LOCKING CONNECTOR AND 28CM OF CATHETER. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE INJECTION PORT WAS RETURNED IN LOCKED POSITION, (B)(4) HOOKS WERE DEPLOYED AND SEVERAL PUNCTURES WERE OBSERVED ON THE SEPTUM. INJECTION PORT AND BAND WERE ALSO COVERED OF BIOLOGICAL DEBRIS. IT WAS NOTED THAT THE TUBING STRAIN RELIEF WAS FLOATING ON THE CATHETER ON THE CATHETER CONNECTION SIDE. EROSION IS A RECOGNIZED ADVERSE EVENT; VISUAL AND FUNCTIONAL ANALYSIS CANNOT CONFIRM PHYSIOLOGICAL EVENTS, THEREFORE NO OTHER ANALYSIS WAS PERFORMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    DURING A ROUTINE TWO YEAR UPPER GI A BAND EROSION WAS REVEALED. THE PATIENT PRESENTED ASYMPTOMATIC. THE DEVICE WAS REMOVAL ON (B)(6), 2011. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention