BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 2061183 · Received April 18, 2011

    Report

    Report Number
    3005992282-2011-00096
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A REALIZE ADJUSTABLE BAND THE BAND WAS REMOVED DUE TO BAND EROSION. THE EROSION WAS DETECTED BY ENDOSCOPY. THE BAND WAS FOUND TO BE INSIDE THE LUMEN OF THE STOMACH. THE TOTAL VOLUME IN THE BAND AT THE TIME OF REMOVAL WAS LESS THAN 7CC. THE TUBING STRAIN RELIEF HAD BECOME DETACHED, SLID DOWN THE TUBING AND WAS POSITIONED ON THE STOMACH. THE STRAIN RELIEF WAS NOT ERODED INTO THE STOMACH. NO ADDITIONAL TREATMENT WAS REQUIRED. THE PATIENT WAS DISCHARGED HOME AND DOING FINE.

    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