BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS SLEEVE K/L MEDIUM

    MDR report key: 1001354 · Received February 19, 2008

    Report

    Report Number
    1017072-2008-00006
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 19, 2008
    Report Date
    January 21, 2008
    Manufacturer
    TYCO HEALTHCARE/ KENDALL
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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 KENDALL/HEALTHCARE THAT A CUSTOMER HAD A PROBLEM WITH THE SCD SLEEVE. THE CUSTOMER REPORTS "MALE WITH AORTIC DISSECTION AND BOWEL INJURIES, PATIENT HAD BRUISING (ECCHYMOSIS HORIZONTAL MARKINGS)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD EXPRESS SLEEVE K/L MEDIUM SCD SLEEVE JOW TYCO HEALTHCARE/ KENDALL 0000217715 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR