BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2833997 · Received November 15, 2012

    Report

    Report Number
    3005992282-2012-00161
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 26, 2012
    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 UNAVAILABLE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE STARTED VOMITING ABOUT 2 WEEKS AGO. UNABLE TO EAT 1/2 CUP AT A MEAL. UNABLE TO DRINK FLUIDS AND HAS GASTRIC REFLUX. NO FEVER. NO PAIN. THE PATIENT STATES THAT AN UPPER GI HAS BEEN SCHEDULE AND WILL CALL BACK WITH THE RESULTS.FOLLOW UP STATEMENT: ADDITIONAL FOLLOW UP IS BEING CONDUCTED. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.

    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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other