BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JRNY BCS II

    MDR report key: 3920952 · Received July 8, 2014

    Report

    Report Number
    1020279-2014-00394
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT HAD BEEN PREVIOUSLY REPORTED UNDER MDR 1020279-2014-00380. PLEASE DISREGARD MDR 1020279-2014-00394.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO WOUND LEAKAGE, POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398625 JRNY BCS II JRNY BCS II FEMORAL OXIN LT SZ 5 JWH SMITH & NEPHEW, INC. 13LM06235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention