BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 3013586 · Received March 20, 2013

    Report

    Report Number
    3005992282-2013-00031
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    October 1, 2012
    Report Date
    March 5, 2013
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTS THAT SHE HAD THE REALIZE BAND IMPLANTED IN (B)(6) 2010. THE PATIENT BEGAN EXPERIENCING PROBLEMS THE BEGINNING OF 2012. THE PATIENT STATES THE BAND WAS TOO TIGHT. THE EXACT NUMBER OF FILLS IS UNKNOWN. THE PATIENT BEGAN TO HAVE ISSUES WITH THE BAND AND WAS EXPERIENCING VOMITING. IN (B)(6) OF 2012, THE PATIENT WAS DIAGNOSIS WITH AN ULCERATED ESOPHAGUS FROM THE VOMITING. AT THAT TIME THE DOCTOR REMOVED 7CC OF FLUID FROM THE BAND. UPON REMOVAL, THE PATIENT DID EXPERIENCE SOME RELIEF AS A RESULT. THE BAND WAS DEFLATED FOR FOUR WEEKS TO ALLOW THE ESOPHAGUS TO HEAL. AFTER THE FOUR WEEKS, 1CC - 5CC WAS PLACED BACK IN THE BAND. AFTER THE FILLS, THE PATIENT BEGAN TO HAVE THE SAME ISSUE OF VOMITING. THE PATIENT HAS BEEN ADVISED A REVISION IS NEEDED TO CORRECT THE MIGRATION OF THE BAND. THE BAND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115628 REALIZE ADJ GASTRIC BAND-C IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention