BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE

    MDR report key: 1933894 · Received December 15, 2010

    Report

    Report Number
    MW5018621
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 16, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6), FEMALE, WHO HAS A REALIZE BAND IN PLACE. PHYSICIAN'S ASSISTANT TRIED TO ADJUST IT AND NOTICED THAT THE FLUID WENT IN BUT DID NOT COME OUT AND SHE WAS SURE SHE WAS IN THE RESERVOIR. ON (B)(6) 2010, MD ACCESSED HER PORT USING STANDARD TECHNIQUE AND WAS ABLE TO PUT IN, ACTUALLY FIND THE RESERVOIR, WHICH IS TIPPED A LITTLE BIT, BUT GETTING INTO THE DIAPHRAGM AND PUSHED IN FLUIDS BUT DID NOT GET FLUID BACK. THIS SUGGESTS THAT THERE IS SOMETHING LEAKING SOMEWHERE. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: MORBID OBESITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJUSTABLE GASTRIC BAND LTI ETHICON ENDO-SURGERY ZLDBCD

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Disability