BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE

    MDR report key: 3893807 · Received June 18, 2014

    Report

    Report Number
    MW5036783
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ETHICON
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PT HAS BEEN EXPERIENCING PAIN AND DISCOMFORT SINCE (B)(6) 2013. IT INCREASINGLY BECAME DIFFICULT FOR HER TO BREATHE DUE TO THE PAIN. THE PT WAS USING THE LAP BAND AND PORT COMPONENTS FOR WEIGHT LOSS AND PORTION CONTROL. WE ONLY REMOVED THE PORT COMPONENT. THE PT STILL HAS THE LAP BAND IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358917 REALIZE LAP BAND LTI ETHICON

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention