BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZONA PLUS 3.0

    MDR report key: 8366460 · Received February 21, 2019

    Report

    Report Number
    MW5084294
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    December 20, 2018
    Report Date
    February 10, 2019
    Manufacturer
    ZONA HEALTH, INC
    Product Code
    BXB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE REQUIRES YOU TO GRIP IT ONE HAND THEN THE OTHER FOR A 12 MINUTE ROUTINE AS HARD AS YOU CAN. THIS DEVICE HAS INJURED THE LOWER PART OF THE THUMB WHERE THE THUMB IS THICKEST AND CONNECTS TO THE HAND. AWAITING AN APPOINTMENT WITH A HAND SURGEON. THE MANUFACTURER RECOMMENDS USING THIS PRODUCT FOR A MINIMUM OF 5 DAYS PER WEEK-ONE PER DAY. THEY SAY DO THIS FOR 12 WEEKS. I DID EXACTLY THIS , I STOPPED USING IT (B)(6) 2018. AS I WRITE, IT IS VERY PAINFUL FOR ME TO HOLD A PEN OR TO DO SIMPLE TASKS LIKE UNSCREWING A JAR TOP . MOST TIMES MY THUMBS HURT WHEN NOT USING THEM. I ASKED THE MANUFACTURER FOR MY MONEY BACK AND THEY REFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153953 ZONA PLUS 3.0 EXERCISER, POWERED BXB ZONA HEALTH, INC ZONA PLUS 3.0

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability