BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS

    MDR report key: 1811550 · Received August 23, 2010

    Report

    Report Number
    9613369-2010-00038
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    SMITH & NEPHEW, INC
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE WASTE SENSOR OF THE CELL-DYN RUBY ANALYZER IS NOT DETECTING A FULL WASTE. A NEW WASTE OUTLET TUBE ASSEMBLY WAS ORDERED FOR REPLACEMENT. NO IMPACT TO PATIENT RESULTS, PATIENT MANAGEMENT, OR USER SAFETY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS REPORTED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS SL-PLUS MIA STEM 1 NON-CEM JDH SMITH & NEPHEW, INC B0706477

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R