BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBV3

    MDR report key: 7553406 · Received May 30, 2018

    Report

    Report Number
    3010078417-2018-00005
    Event Type
    Injury
    Date Received
    May 30, 2018
    Date of Event
    August 21, 2017
    Report Date
    May 30, 2018
    Manufacturer
    ACTEGY LTD
    Product Code
    NUH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S ANALYSIS: THE DEVICE IS NOT CONTRAINDICATED FOR USE IN THE PRESENCE OF VARICOSITIES. THE INSTRUCTIONS FOR USE (IFU) DESCRIBES AN ADEQUATE SETTING AS WHEN THE INDIVIDUAL CAN "FEEL THE MILD ELECTRICAL IMPULSES IN YOUR FEET AND THE MUSCLES IN THE CALF VISIBLY PULSING OR TWITCHING BUT AT A LEVEL THAT IS NOT UNCOMFORTABLE". THE DEVICE INTENSITY RANGE IS 0-99 (0 BEING THE LOWEST, AND 99 BEING THE HIGHEST INTENSITY SETTING). THE INDIVIDUAL HAS STATED THAT THEY USED THE DEVICE AT AN INTENSITY OF "9-12". WE BELIEVE IT IS MOST LIKELY THAT THE USER IN THIS CASE, (B)(6), HAS NOT USED THE DEVICE AS DESCRIBED IN THE IFU. THE INTENSITY HAS NOT BEEN APPLIED AT A SUFFICIENTLY HIGH ENOUGH INTENSITY TO CREATE THE REQUIRED MUSCLE CONTRACTION. WE EXPECT THAT THE DEVICE WOULD HAVE HAD LITTLE EFFECT AT THIS LEVEL OF INTENSITY, IF AT ALL. THEREFORE WE BELIEVE THE MOST LIKELY CAUSE OF VARICOSE VEINS IN THIS (B)(6) LADY, IS THE NATURAL PROGRESSION OF HER UNDERLYING MEDICAL CONDITION. CASE CLOSED AS PATIENT UNDERLYING MEDICAL CONDITION IS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    PLEASE NOTE: FOLLOWING AN FDA INSPECTION AT ACTEGY LTD BETWEEN MARCH 5-8, 2018 BY MR. (B)(4) IT WAS IDENTIFIED THIS INCIDENT SHOULD HAVE BEEN REPORTED TO FDA. THEREFORE, THE FOLLOWING INCIDENT IS BEING REPORTED RETROSPECTIVELY: FOLLOWING THE PURCHASE OF THE NEW DEVICE AND USE FOR 6 MONTHS (B)(6) REPORTED THAT SHE HAS SUFFERED FROM VARICOSITIES ON BOTH HER LEGS AND THAT HER VEINS HAVE GRADUALLY INCREASED IN SIZE SINCE THE FIRST AND SUBSEQUENT USE OF THE DEVICE ((B)(6) 2017). ACCORDING TO (B)(6) THE DEVICE WAS PURCHASED TO RELIEVE A "TINGLING SENSATION" IN HER LEGS AND WAS BEING USED FOR 30 MINUTES EVERY DAY ON INTENSITY LEVELS BETWEEN 9 AND 12. ON (B)(6) 2017 (B)(6) DOCTOR PROVIDED A LETTER TO ACTEGY LTD ADVISING THAT HER PATIENTS VARICOSE VEIN CONDITION HAD OCCURRED FOLLOWING THE USE OF THE DEVICE WHICH HAD NOT EXISTED PRIOR TO THIS. THE DOCTOR ALSO ADVISED THAT THESE SYMPTOMS WOULD LIKELY REQUIRE SPECIALIST INTERVENTION (LASER OR LOCAL SCLEROSIS) FOLLOWING THE AESTHETIC CONCERNS RAISED BY HER PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396374 CBV3 CIRCULATION BOOSTER NUH ACTEGY LTD CBV3

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR