BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2213022 · Received August 8, 2011

    Report

    Report Number
    2213022
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 8, 2011
    Manufacturer
    SMITH & NEPHEW,INC., ENDOSCOPY DIVISION
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR KNEE ARTHROSCOPY. AT THE END OF PROCEDURE, IT WAS NOTED THAT THE THIGH WAS SWOLLEN WITH MODERATE ERYTHEMA AND SKIN TURGOR WAS TAUT. PT WAS ASSESSED. APPEARANCES SUGGEST FLUID FROM ARTHROSCOPY ENTERED THE SURROUNDING TISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DYONICS 25 FLUID MANAGEMENT SYSTEM HRX SMITH & NEPHEW,INC., ENDOSCOPY DIVISION 7211010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR