BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCUTHERM4

    MDR report key: 4024855 · Received August 14, 2014

    Report

    Report Number
    MW5037769
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    March 26, 2014
    Report Date
    August 13, 2014
    Manufacturer
    THERMOTEK
    Product Code
    JOW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS USING THE VACUTHERM4 (THERMOTEK) ICELESS COLD AND DVT PROPHYLAXIS THERAPY POST-OP R KNEE ACL REPAIR (B)(6) 2014, 5 DAYS AFTER SURGERY WHEN USING THE MACHINE, MY R CALF BECAME SWOLLEN, WARM, TENDER AND VERY PAINFUL TO TOUCH. I ALSO HAD A BRUISE ALONG MY TIBIA. I REALIZED THAT THE SLEEVE WAS NOT DEFLATING AND I CALLED THE REP AT (B)(4) WHO CAME OUT, VERIFIED THE PROBLEM AND REPLACED THE SLEEVE. THE SWELLING AND PAIN CONTINUED AND I DEVELOPED NERVE PAIN AND TEMPERATURE REGULATION PROBLEMS. I WAS EVENTFULLY DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME THAT CAN BE A DIRECT RESULT OF COMPRESSION. MY LEG WAS LITERALLY TRAPPED BETWEEN THE INFLATED SLEEVE AND LEG BRACE. RECENTLY, I WAS TOLD BY THE REP THAT BECAUSE OF MY EXPERIENCE, THE DOCTOR IS NO LONGER USING THIS MACHINE. I HAVE HAD TO TAKE OFF WORK, SEE MULTIPLE MD'S, BE ON SEVERAL MEDICATIONS AND THERAPIES INCLUDING ACUPUNCTURE, PHYSICAL THERAPY AND BIOFEEDBACK AND AM STILL BEING TREATED FOR THE NERVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486985 VASCUTHERM4 VASCUTHERM THERAPY JOW THERMOTEK VACUTHERM

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R