BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1821864 · Received August 31, 2010

    Report

    Report Number
    3005992282-2010-00256
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 13, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BAND EROSION WAS REPORTED BY THE CONSUMER. CONSUMER STATES RECEIVING SEVERAL FILLS, BUT UNKNOWN DATES AND HOW MUCH EACH FILL WAS. IN (B)(6) 2010, THE CONSUMER FELT THAT THE BAND WAS TOO TIGHT. THE SURGEON EXTRACTED SOME FLUID AND AFTER THAT THE CONSUMER REPORTED NOT FEELING ANY RESTRICTION. IN (B)(6) 2010, THE PATIENT HAD TWO SMALL FILLS AND STILL DID NOT FEEL RESTRICTION. ON (B)(6) 2010 AN UPPER GI WAS PERFORMED AND REVEALED TH BAND HAD ERODED INTO HIS STOMACH. IN A CONVERSATION WITH THE SURGEON ON (B)(6) 2010, HE VERIFIED THE REPORTED INFORMATION. IN ADDITION, HE STATED THAT SINCE THE PATIENT COMPLAINED OF THE BAND BEING TOO TIGHT IN (B)(6) AND AFTER REMOVING A COUPLE OF CCS, THE PATIENT HAS NOT BE ABLE TO ACHIEVE RESTRICTION. THE PATIENT HAS HAD EXCELLENT RESULTS WITH A 75% EWL. THE SURGEON CONFIRMS THAT AN UPPER GI WAS DONE BUT NOT CONCLUSIVE OF BAND EROSION BUT WAS CONFIRMED VIA AN ENDOSCOPY ON (B)(6) 2010.

    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 Required Intervention