BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 2122836 · Received June 14, 2011

    Report

    Report Number
    3005992282-2011-00134
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 19, 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

    THE CUSTOMER REPORTS THAT POST-IMPLANT OF A REALIZE ADJUSTABLE BAND, THE BAND HAD TO BE REMOVED DUE TO SLIPPAGE. THE PATIENT HAD THREE FILLS. THERE WAS A TOTAL OF 9CC IN THE BAND AT THE TIME OF EXPLANT. THE PATIENT BEGAN TO EXPERIENCE HEART BURN AND REFLUX. IN (B)(6) 2010 IT WAS DETECTED BY X-RAY THAT THE BAND HAD SLIPPED. AT THAT POINT ALL THE FLUID WAS REMOVED FROM THE BAND WITH THE EXPECTATION THAT IT WOULD RETURN TO ITS ORIGINAL POSITION. IN THE BEGINNING OR MID (B)(6) 2011, THE BAND HAD RETURNED TO ITS ORIGINAL POSITION: 4CC WERE PLACED INTO THE BAND. IT WAS LATER DETECTED THAT THE BAND HAD SLIPPED AGAIN AFTER THE FILL. THE BAND WAS REMOVED.

    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