BEUDAMED
    FDA Adverse Event Other Summary report: N

    KENDALL SEQUENTIAL COMPRESSION DEVICE

    MDR report key: 629390 · Received August 18, 2005

    Report

    Report Number
    1017072-2005-00005
    Event Type
    Other
    Date Received
    August 18, 2005
    Date of Event
    July 8, 2005
    Report Date
    July 22, 2005
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN 2005 THAT A CUSTOMER HAD A PROBLEM WITH A SEQUENTIAL COMPRESSION SLEEVE. ACCORDING TO THE CUSTOMER "BRUISING ON LOWER LEGS OF ONE TOTAL HIP PATIENT, PATIENT HAD LOTS OF EDEMA AND WAS TAKING LOVENOX (LMWH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL SEQUENTIAL COMPRESSION DEVICE SEQUENTIAL COMPRESSION SLEEVE JOW TYCO HEALTHCARE/KENDALL NA 5037

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other