BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCD COMFORT SLEEVE KNEE LENGTH SMALL

    MDR report key: 3671917 · Received February 20, 2014

    Report

    Report Number
    1017072-2014-00001
    Event Type
    Other
    Date Received
    February 20, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 29, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY ON THE WAY, UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A COMPRESSION SLEEVE. THE CUSTOMER STATES THAT AFTER 20 HOURS OF USE, THE PAT GOT DERMAL INFLAMMATION ON THE OUTSIDE OF RIGHT LEG. THE PT STARTED WEARING THE SLEEVE AT THE TIME OF RESPIRATORY SURGERY PERFORMED IN THE MORNING OF (B)(6) 2014. THE PT WAS TRANSFERRED TO HCU, AND THE SLEEVE WAS REMOVED AFTER THE SURGERY AND PUT ON AGAIN AT 14:50 ON THE SAME DAY WEARING SURGICAL STOCKING AT 0:00, THE SURGICAL STOCKING WAS REMOVED FROM THE PATIENT BY THE PHYSICIAN'S ADVICE AND PLACED THE SLEEVE DIRECTLY ON THE LEG. AT 9:00, THE PATIENT HAD A DRY BATH, BUT THERE WAS NO SYMPTOM OF INFLAMMATION CONFIRMED AT THAT TIME. AT 10:30, THE PT STOPPED IPC TREATMENT AND TRANSFERRED TO THE GENERAL WARD. ON (B)(6) 2014, 15:30, IT WAS FOUND THAT THE PT HAD INFLAMMATION ON HER LEG. IT WAS NOT CONFIRMED HOW LONG SHE HAD IT FOR AND WHEN IT HAPPENED, BECAUSE ON (B)(6) 2014, THE PT DID NOT WANT TO TAKE A BATH DUE TO PAIN CAUSED BY THE RESPIRATORY SURGERY. THE PT HAD BETAMETHASONE DIPROPIONATE FOR THE INFLAMMATION, BUT IT WAS NOT HEALED AS EXPECTED. THE PATIENT HAD NO HISTORY OF ALLERGIC REACTION. IN ADDITION, THE SYMPTOM OF INFLAMMATION APPEARED ONLY ON ONE LEG (RIGHT) EVEN THOUGH SLEEVES WERE WORN ON BOTH LEGS. A PIECE OF SOAP WAS USED FOR DRY BATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106545 SCD COMFORT SLEEVE KNEE LENGTH SMALL COMPRESSION SLEEVE JOW COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 74021 31190Y01X

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other