BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUNTLEIGH FP5000 SYSTEM

    MDR report key: 212534 · Received March 3, 1999

    Report

    Report Number
    2431480-1999-00003
    Event Type
    Injury
    Date Received
    March 3, 1999
    Report Date
    March 3, 1999
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Product Code
    JOW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 2/10/99 COMPANY SALES REP WAS NOTIFIED BY HOSPITAL THAT FIVE ORTHOPEDIC PATIENTS, RANGING IN AGES 76-81 AND INVOLVING BOTH SEXES, HAD DEVELOPED HEEL BLISTERS WHILE USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUNTLEIGH FP5000 SYSTEM EXTERNAL PNEUMATIC FOOT COMPRESSION JOW HUNTLEIGH HEALTHCARE, INC. FP5000 PUMP/USED WITH: NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention