BEUDAMED
    FDA Adverse Event Other Summary report: N

    TED K/L LGE REG X12

    MDR report key: 1897548 · Received November 8, 2010

    Report

    Report Number
    9710592-2010-00002
    Event Type
    Other
    Date Received
    November 8, 2010
    Report Date
    October 25, 2010
    Manufacturer
    COVIDIEN
    Product Code
    DWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH TED COMPRESSION STOCKINGS. THE CUSTOMER STATES A MALE PT PRESENTED AT THE (B)(6) CLINIC - ULTRASOUND CONFIRMED CALF VEIN THROMBUS IN LEFT LEG. CLEXANE WAS ADMINISTERED ON (B)(6) 2010, WITH WARFARIN ADMINISTRATION COMMENCING ON (B)(6) 2010. THE SAME DAY, A KNEE LENGTH TED STOCKING WAS APPLIED TO LEFT LEG AFTER CORRECT MEASUREMENT. STOCKING WAS REMOVED ON (B)(6) 2010, AND BRUISING/INTERNAL BLEED MARKING WAS NOTICED AT SEVERAL POINTS FROM THE CALF WITH BLOOD POOLING AT THE ANKLE. THE PT EXPERIENCED NO PAIN AND REMAINS TREATED AT THE (B)(6) CLINIC ON WARFARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TED K/L LGE REG X12 COMPRESSION STOCKING DWL COVIDIEN 7203 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other