BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSETMV MV ENDURANCE 40 G

    MDR report key: 925874 · Received October 9, 2007

    Report

    Report Number
    1818910-2007-03350
    Event Type
    Injury
    Date Received
    October 9, 2007
    Report Date
    September 1, 2007
    Manufacturer
    DEPUY GMW
    Product Code
    JDK
    PMA / PMN Number
    P960001/S001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LEGAL PAPERS ALLEGE THAT BILATERAL PATIENT SUFFERS FROM SEVERE PAIN AND DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSETMV MV ENDURANCE 40 G 87JDK JDK DEPUY GMW NA F389Z40

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Required Intervention