BEUDAMED
    FDA Adverse Event Other Summary report: N

    KENDALL SCD RESPONSE-COMPRESS SYSTEM

    MDR report key: 616541 · Received June 23, 2005

    Report

    Report Number
    1310379-2005-00007
    Event Type
    Other
    Date Received
    June 23, 2005
    Date of Event
    June 5, 2005
    Report Date
    June 6, 2005
    Manufacturer
    WATERTOWN
    Product Code
    JOW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE IN 2005 THAT A CUSTOMER HAD A PROBLEM WITH SCD SEQUENTIAL COMPRESSION SLEEVE. ACCORDING TO THE CUSTOMER THE SEQUENTIAL COMPRESSION SLEEVE CAUSED BRUISING ON PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other