BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX CONTINOUS WAVE PUMP

    MDR report key: 533344 · Received June 17, 2004

    Report

    Report Number
    MW1032379
    Event Type
    Injury
    Date Received
    June 17, 2004
    Date of Event
    May 26, 2004
    Report Date
    May 26, 2004
    Manufacturer
    ARTHREX (OCI)
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS A KNEE ARTHROSCOPY WITH A LATERAL RELEASE. A TOURNIQUET WAS NOT USED. AFTER THE PROCEDURE IT WAS NOTED THAT THE PT'S LEG WAS VERY SWOLLEN FROM KNEE TO THE GROIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX CONTINOUS WAVE PUMP ARTHROSCOPY PUMP HRX ARTHREX (OCI) AR6400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O