BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL SCD

    MDR report key: 477795 · Received August 5, 2003

    Report

    Report Number
    MW1029250
    Event Type
    Malfunction
    Date Received
    August 5, 2003
    Date of Event
    August 3, 2003
    Report Date
    August 5, 2003
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SEQUENTIAL COMPRESSION SLEEVES WOULD NOT INFLATE. APPEAR TO BE ABLE TO HEAR AIR LEAKING. THIS PRODUCT WAS NEW, EXCHANGED FOR ANOTHER WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL SCD SEQUENTIAL COMPRESSION SLEEVE JOW TYCO HEALTHCARE/KENDALL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other