BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TEDS

    MDR report key: 2564652 · Received April 26, 2012

    Report

    Report Number
    1017072-2012-00004
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Report Date
    April 5, 2012
    Manufacturer
    COVIDIEN
    Product Code
    DWL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A TED STOCKING. THE CUSTOMER REPORTS A PT WHO WAS WEARING TEDS ENDED UP HAVING SEVERE HEMATOMAS AND WOUNDS ON THEIR LEGS. THE PT'S WOUNDS WERE DRESSED. THERE WAS NO UNANTICIPATED TISSUE LOSS, TISSUE DAMAGE OR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TEDS TED STOCKING DWL COVIDIEN UNKNOWN TEDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN