BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN AV IMPULSE FOOT COMPRESSION COVER

    MDR report key: 3020741 · Received March 21, 2013

    Report

    Report Number
    MW5029455
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 12, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED DVT ON OPERATIVE LEG POST OP DAY 2 FOLLOWING A LEFT TOTAL KNEE ARTHROSCOPY. STAFF REPORTED ISSUES WITH SCD PUMP; SWITCHED PUMPS X 2 AND FOOT SLEEVE X 3. AT LEAST 2 OF 3 FOOT SLEEVES WERE DEFECTIVE AS DETERMINED BY OUR CLINICAL ENGINEERING DEPARTMENT. NONE OF THE SLEEVES WERE KEPT BY STAFF FOR INVESTIGATION. DATE OF USE: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117646 COVIDIEN AV IMPULSE FOOT COMPRESSION COVER FOOT PUMP SLEEVE JOW COVIDIEN
    117647 COVIDIEN AV IMPULSE FOOT COMPRESSION COVER FOOT PUMP SLEEVE JOW COVIDIEN
    117648 COVIDIEN AV IMPULSE FOOT COMPRESSION COVER FOOT PUMP SLEEVE JOW COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention