BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1823875 · Received September 2, 2010

    Report

    Report Number
    3005992282-2010-00263
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 17, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ONE VELOCITY INJECTION PORT WITH THE LOCKING CONNECTOR, TUBING STRAIN RELIEF AND 3CM OF CATHETER WERE RETURNED FOR ANALYSIS. EVENTS THAT ARE PHYSIOLOGICAL IN NATURE SUCH AS INFECTION CANNOT BE CONFIRMED THROUGH PRODUCT ANALYSIS. A REVIEW OF THE PRODUCT'S INSTRUCTION FOR USE (IFU) WAS PERFORMED WITH RESPECT TO INFECTION. IT IS NOTED THAT INFECTION IS A RECOGNIZED ADVERSE EVENT ASSOCIATED WITH GASTRIC BANDING AND THE REALIZE GASTRIC BAND. POTENTIAL CAUSES OF INFECTION INCLUDE, AMONG OTHERS, LACK OF ASEPTIC TECHNIQUE DURING IMPLANT OR DURING SUBSEQUENT ADJUSTMENTS OF THE DEVICE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS IN RELATION TO THE ALLEGED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A REALIZE BAND PLACEMENT, THE PATIENT HAD A HEMATOMA AT THE PORT SITE. THE SITE DID NOT COMPLETELY HEAL AFTER THE SURGERY AND LATER A PORT SITE INFECTION OCCURRED. THE PORT WAS REMOVED ON (B)(6)2010. THE TUBING WAS DROPPED BACK IN THE ABDOMEN AND A NEW PORT WILL BE PLACED WHEN THE SITE IS HEALED. THE PATIENT WAS DISCHARGED HOME WITHOUT ANY COMPLICATIONS.

    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 ZJPBF3

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention