BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS COMP SYSTEM JAPAN

    MDR report key: 1052860 · Received May 27, 2008

    Report

    Report Number
    1310379-2008-00004
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 23, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN 2008 THAT A CUSTOMER HAD A PROBLEM WITH A SCD SYSTEM. THE CUSTOMER REPORTS A PT HAD REDNESS OF THE SKIN WHICH OCCURRED ALONG THE PART OF THE LEG WHERE THE EDGE OF THE FOOT CUFF TOUCHED. HOWEVER, THE CUSTOMER IS NOT SURE IF THE INCIDENT IS CAUSED BY THE SCD AS A STOCKING MANUFACTURED BY ANOTHER CO WAS USED WITH THE SCD. A REDNESS AND PALSY ON THE RIGHT FOOT OCCURRED. THE PT REMAINS IN THE HOSP BECAUSE OF THE PRIMARY DISEASE AND IS STILL HAVING PALSY ON THE RIGHT BIG TOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD EXPRESS COMP SYSTEM JAPAN SCD PUMP JOW TYCO HEALTHCARE/KENDALL 95257 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK