BEUDAMED
    FDA Adverse Event Summary report: N

    FMS DUO +

    MDR report key: 1837685 · Received September 1, 2010

    Report

    Report Number
    1837685
    Date Received
    September 1, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 1, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    DURING KNEE ARTHROSCOPY DR. NOTICED THAT THE PATIENT'S LEG WAS "TIGHT" AND THAT THE PUMP SEEMED TO BE RUNNING AT A PACE FASTER THAN NORMAL. PUMP WAS CHANGED AND PROBLEM CONTINUED. TUBING WAS CHANGED AND FLUID PACE APPEARED TO BE NORMAL.====================== MANUFACTURER RESPONSE FOR PUMP, ARTHROSCOPY, (BRAND NOT PROVIDED)======================SALES REP CAME IMMEDIATELY TO INSPECT DEVICE.====================== MANUFACTURER RESPONSE FOR PUMP, ARTHROSCOPY, (BRAND NOT PROVIDED)======================SALES REP CAME IMMEDIATELY AND INSPECTED DEVICES.====================== MANUFACTURER RESPONSE FOR TUBING, ARTHROSCOPY, (BRAND NOT PROVIDED)======================SALES REP CAME IN IMMEDIATELY TO INSPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMS DUO + PUMP, ARTHROSCOPY HRX DEPUY MITEK FMS DUO + *
    2 FMS DUO + PUMP, ARTHROSCOPY HRX DEPUY MITEK * *
    3 FMS DUO + STERILE ZONE KIT TUBING, ARTHROSCOPY HRX DEPUY MITEK 4549 BBBA10071

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR NO OTHER THERAPIES