BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1931210 · Received December 17, 2010

    Report

    Report Number
    3005992282-2010-00449
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 6, 2010
    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 PATIENT REPORTS THAT POST IMPLANT OF THEIR LAPAROSCOPIC ADJUSTABLE BAND ON APPROXIMATELY NOVEMBER 9, 2010, THE PATIENT DEVELOPED A PAINFUL LUMP AT THE PORT SITE. DIAGNOSTIC TEST PERFORMED AND NOTHING WAS FOUND. ON (B)(6), 2010 THE SURGEON ASPIRATED SOME FLUID AND A CULTURE WAS PERFORMED. THE PATIENT WAS DIAGNOSED WITH AN INFECTION AT THE PORT SITE. ON (B)(6), THE BAND WAS REMOVED. THE PATIENT WAS PLACED ON ANTIBIOTIC AND REMAINED IN THE HOSPITAL FOR SIX DAYS AFTER THE BAND WAS REMOVED. THE PATIENT CONTINUED TO TAKE THE ANTIBIOTICS FOR AN ADDITIONAL SEVEN DAY AFTER BEING RELEASED FROM THE HOSPITAL. THE PATIENT IS CURRENTLY DOING FINE. ADDITIONAL FOLLOW UP IS BEING CONDUCTED. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.

    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