BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCD EXPRESS SLEEVE K/L MEDIUM

    MDR report key: 1590477 · Received January 27, 2010

    Report

    Report Number
    1017072-2010-00015
    Event Type
    Other
    Date Received
    January 27, 2010
    Date of Event
    December 1, 2009
    Report Date
    January 20, 2010
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 1/20/2010, THAT A CUSTOMER HAD AN ISSUE WITH A SCD COMPRESSION SLEEVE. THE CUSTOMER REPORTS THAT THE PATIENT EXPERIENCED BLISTERING ALL OVER THEIR LEGS WHILE WEARING SCD EXPRESS SLEEVES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other