BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCD COMPRESSION SYSTEM

    MDR report key: 616137 · Received June 22, 2005

    Report

    Report Number
    1310379-2005-00005
    Event Type
    Other
    Date Received
    June 22, 2005
    Date of Event
    May 1, 2004
    Report Date
    June 10, 2005
    Manufacturer
    WATERTOWN
    Product Code
    JOW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN JUNE 2005 THAT A CUSTOMER HAS A PROBLEM WITH SCD COMPRESSION SLEEVE. ACCORDING TO THE CUSTOMER WHEN THE SEQUENTIAL COMPRESSION SLEEVES WERE REMOVED FROM THE PT'S LEGS, THERE WAS A 7 CM X 4.5CM BLISTER ON THE RIGHT LATERAL ASPECT OF THE CALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD COMPRESSION SYSTEM SEQUENTIAL COMPRESSION SLEEVE JOW WATERTOWN NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other