BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY I BCS/RENASY

    MDR report key: 3932873 · Received July 14, 2014

    Report

    Report Number
    1020279-2014-00418
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    September 13, 2013
    Report Date
    July 14, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410478 JOURNEY I BCS/RENASY JOURNEY FEM OX NP BCS RT SZ 6 JWH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R (B)(4)| (B)(4)| (B)(4)