BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2181890 · Received July 28, 2011

    Report

    Report Number
    3005992282-2011-00161
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 5, 2011
    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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT POST IMPLANT OF A REALIZE BAND, SHE HAD THREE FILLS FOR A TOTAL 7CCS. AFTER THE LAST FILL ON (B)(6), 2011 SHE HAD ABDOMINAL PAIN. PATIENT RETURNED TO SURGEON'S OFFICE IN (B)(6) AND THE SURGEON REMOVED 2 CCS OF FLUID. SHE RETURNED AGAIN, DATE UNKNOWN, DUE TO BACK AND CHEST PAIN. AN UPPER GI WAS ORDERED AND NO SLIPPAGE WAS FOUND. A STRESS TEST AND AN ECHO THAT WAS PERFORMED WITH NO INDICATION OF AN ISSUE. ON (B)(6) 2011 THE PORT WAS REPLACED. THE PATIENT STATES THAT THE SURGEON INDICATED, "THE PORT WAS REMOVED DUE TO RECALL AND DEFECTIVE PORT. HE WAS UNABLE TO REMOVE FLUID DUE TO A ONE WAY VALVE EFFECT. DURING PORT REVISION SURGEON, THE "FLANGE" WAS NOTED TO BE DETACHED." THIS WAS DONE AS AN OUTPATIENT PROCEDURE. THE PATIENT REPORTS TO BE DOING FINE NOW. THE LAST FILL WAS (B)(6) 2011 AND PATIENT RECEIVED 3CCS.

    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 58 YR Required Intervention