BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE

    MDR report key: 2915729 · Received January 10, 2013

    Report

    Report Number
    MW5028527
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    April 14, 2006
    Report Date
    December 24, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY SURGEON USED THE MEDTRONIC INFUSE WHICH HAS CAUSED ME MANY PROBLEMS, INCLUDING SIGNIFICANT PAIN, REQUIRED ME TO UNDERGO AN ADDITIONAL SURGERY, AS WELL AS MENTAL ANGUISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14761 MEDTRONIC INFUSE BONE FILLER NEK MEDTRONIC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R