BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCULAR UNK

    MDR report key: 1562883 · Received December 16, 2009

    Report

    Report Number
    1017072-2009-00017
    Event Type
    Other
    Date Received
    December 16, 2009
    Report Date
    December 3, 2009
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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 12/03/2009 THAT A CUSTOMER HAD AN ISSUE WITH A SCD COMPRESSION SLEEVE. CUSTOMER STATES THAT WHILE WEARING COMPRESSION SLEEVES, THE PT GOT BILATERAL BRUISING. WHEN THE BRUISING WAS OBSERVED COMPRESSION SLEEVES WERE REMOVED AND PT WAS MOVED TO FOOT CUFF COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULAR UNK SCD COMPRESSION SLEEVE JOW COVIDIEN UNK VT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK