BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1982866 · Received February 9, 2011

    Report

    Report Number
    3005992282-2011-00040
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 28, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED POST IMPLANT OF A REALIZE BAND, SUBJECT DEVELOPED A RIGHT UPPER QUADRANT INCISIONAL HERNIA. IT WAS REPAIRED AND THE INJECTION PORT WAS REPLACED. THE PATIENT WAS DISCHARGED HOME SAME DAY. THE DEVICE WILL NOT BE RETURNED. IT WAS DISCARDED.

    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 50 YR Required Intervention