BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRON DVT PROPHYLAXIS SYSTEM

    MDR report key: 1610150 · Received February 11, 2010

    Report

    Report Number
    1610150
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    December 13, 2009
    Report Date
    February 11, 2010
    Manufacturer
    HUNTLEIGH HEALTH CARE
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STAFF SHOWED RISK MGR ONE PT WITH REDDENED SKIN AND INDENTATION. STAFF NURSES REPORT ONCE PRODUCT IS APPLIED, THE EXIT TUBING PUTS PRESSURE ON THE PT'S SKIN. WHEN PT MOVES, EVEN IF PRODUCT IS SNUG, TUBING IS UNDER THE PT, AND WEIGHT OF EXTREMITY AGAINST THE TUBE, WHICH IS LYING ON THE MATTRESS, CAUSES REDNESS AND INDENTATION IF PT IS EDEMATOUS. COULD TUBE PROTRUDE ELSEWHERE OR EXIT WITH SOME KIND OF GUIDE AWAY FROM BODY? (STAFF SAID THIS HAS HAPPED WITH OTHER PTS). WHILE I AM NOT AWARE OF PROGRESSION OF REDNESS TO MORE SERIOUS PRESSURE ULCERS, REDNESS CAN BE CONSIDERED STAGE 1 PRESSURE ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTRON DVT PROPHYLAXIS SYSTEM NONE JOW HUNTLEIGH HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other MODEL # AC500, AC550 AND AC600| THIS PRODUCT IS USED WITH FLORTON PUMPS