BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1914138 · Received December 3, 2010

    Report

    Report Number
    3005992282-2010-00386
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAS HAD 6 FILLS WITH NO RESTRICTION POST IMPLANT A REALIZE BAND. WITH EACH FILL, THERE HAS BEEN LESS FLUID WITHDRAWN THAT PREVIOUSLY INJECTED. ON THE LAST FILL, THE PA INJECTED 10 CC INTO THE PORT AND IMMEDIATELY WAS ONLY ABLE TO WITHDRAW 4 CC. NEXT FILL WILL BE DONE UNDER FLUOROSCOPY. ADDITIONAL FOLLOW UP IS BEING CONDUCTED. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATING THE DURING THE LAP DIAGNOSTIC IT WAS DETERMINED THAT THE PORT HAD DISCONNECTED. IT WAS SURGICALLY PAIRED. THE PATIENT HAS BEEN SEEN IN THE OFFICE FOR THEIR FIRST FOLLOW UP AND THERE WERE NO PROBLEMS WITH THE PORT. THE PATIENT IS DOING FINE.

    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