BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER ANTI EMBOLISM SYSTEM

    MDR report key: 43894 · Received October 21, 1996

    Report

    Report Number
    MW1010106
    Event Type
    Malfunction
    Date Received
    October 21, 1996
    Date of Event
    October 4, 1996
    Report Date
    October 10, 1996
    Manufacturer
    ALBA-WALDENSIAN, INC.
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER SEVERAL DAYS OF WEARING STOCKINGS, NOTED ABRASION TO RIGHT UPPER ANKLE AND CREASES IN LEFT ANKLE. STOCKINGS "TRAVEL" CONSTANTLY. THEY DO NOT STAY IN PLACE. HARD/SHARP EDGE TO PLASTIC AIR BLADDER RUBS UPPER ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER ANTI EMBOLISM SYSTEM P.A.S. STOCKINGS JOW ALBA-WALDENSIAN, INC. P.A.S. II *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other