BEUDAMED
    FDA Adverse Event Other Summary report: N

    KENDAL SEQUENTIAL COMPRESSION DEVICE

    MDR report key: 629395 · Received August 18, 2005

    Report

    Report Number
    1017072-2005-00006
    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 "PATIENT WITH TOTAL KNEE REPLACEMENT HAD BRUISING. PATIENT HAD LOTS OF EDEMA AND WAS ON LOVAMEX (LMWH).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN