BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS SLEEVE K/L MEDIUM

    MDR report key: 1053546 · Received May 28, 2008

    Report

    Report Number
    1017072-2008-00008
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 05/27/2008. 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 THAT A CUSTOMER HAD AN ISSUE WITH THE SCD EXPRESS SLEEVE. THE CUSTOMER REPORTS THAT A PT HAD BAD SKIN BREAKDOWN DUE TO SCD GARMENT. THE CUSTOMER REPORTS THAT THEY FEEL THE GARMENTS WERE DIGGING INTO THE PTS' SKIN BEHIND THE KNEE AND THAT THE GARMENTS MIGHT HAVE BEEN TOO TIGHT TO BEGIN WITH. BRUISING LINES ON THE PTS' LEGS WHERE THE LEG SLEEVES WERE ON THE LEGS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD EXPRESS SLEEVE K/L MEDIUM SCD EXPRESS SLEEVE JOW TYCO HEALTHCARE/KENDALL 9529 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK