BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1894120 · Received November 9, 2010

    Report

    Report Number
    3005992282-2010-00355
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 27, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 A REALIZE ADJUSTABLE BAND, THE PATIENT PRESENTED POST WITH EPIGASTRIC PAIN, FEVER AND ELEVATED WHITE BLOOD COUNT. A CT SCAN AND EGD WERE PERFORMED AND SHOWED A BAND INFECTION. (B)(6) 2010, A DIAGNOSTIC LAPAROSCOPY WAS PERFORMED AND THE BAND REMOVED. IT WAS NOTED THAT THERE WAS NOTHING VISUALLY WRONG WITH THE DEVICE. THERE WAS WHITE PUSS OR BARIUM PRESENT AROUND THE BAND. A DRAIN WAS INSERTED. THE PATIENT IS IMPROVING; THE WHITE COUNT IS NORMAL. THE SURGEON PERFORMED AN ADDITIONAL LAPAROSCOPY ON (B)(6) 2010 TO TEST FOR A GASTRIC LEAK. NO LEAK WAS FOUND. THE SURGEON REPLACED DRAIN AND WILL FOLLOW THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention