BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 2942060 · Received February 4, 2013

    Report

    Report Number
    3005992282-2013-00010
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 21, 2009
    Report Date
    January 14, 2013
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A ADJUSTABLE GASTRIC BAND, THE PATIENT HAD DEVELOPED A LARGE HIATAL HERNIA. IT IS BELIEVED THAT THE HIATAL HERNIA WAS PRESENT AT THE TIME OF THE INITIAL PROCEUDRE, HOWEVER, IT WAS NOT SIGNIFICANT. SURGERY IS RECOMMENDED TO REPAIR THE HIATAL HERNIA.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
    46933 REALIZE ADJ GASTRIC BAND STR IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other