BEUDAMED
    FDA Adverse Event Other Summary report: N

    KNEE LENGTH MED/REG TED

    MDR report key: 2288548 · Received October 3, 2011

    Report

    Report Number
    1017072-2011-00009
    Event Type
    Other
    Date Received
    October 3, 2011
    Report Date
    September 15, 2011
    Manufacturer
    COVIDIEN
    Product Code
    DWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A PAIR OF TED STOCKINGS. THE CUSTOMER STATED THAT A PT HAD AN ALLERGIC REACTION (SHORTNESS OF BREATH, ITCHING AND HIVES) TO THE T.E.D. ANTI EMBOLISM STOCKINGS. THE PT HAD A KNOWN ALLERGIC REACTION TO LATEX. THE PT WAS SENT TO THE EMERGENCY ROOM WHERE SHE WAS GIVEN AN IV AND PRESCRIPTION MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNEE LENGTH MED/REG TED TED ANTI EMBOLISM STOCKINGS DWL COVIDIEN 7115 66975746

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention