BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SRV S&N 25 SYSTEMS

    MDR report key: 2210746 · Received August 12, 2011

    Report

    Report Number
    1643264-2011-00015
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    SMITH & NEPHEW ASDD OKC MANUFACTURING SITE
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    TOO MUCH FLUID IN THE JOINT AND CAUSED THE LEG TO EXPAND AND TRAVEL TO THE UPPER LEG. PATIENT WAS KEPT OVERNIGHT DUE TO SWELLING IN THE GROIN AREA. PATIENT RELEASED NEXT MORNING AND IS RECOVERING AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SRV S&N 25 SYSTEMS SVCE REPL,CONTROL UNIT, DYONICS 25 HRX SMITH & NEPHEW ASDD OKC MANUFACTURING SITE 7211010S ZN04388

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization