BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALANCEON

    MDR report key: 10676976 · Received October 13, 2020

    Report

    Report Number
    MW5097207
    Event Type
    Injury
    Date Received
    October 13, 2020
    Date of Event
    August 24, 2020
    Report Date
    October 9, 2020
    Manufacturer
    BULLSONE CO., LTD.
    Product Code
    FMP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BOUGHT THIS PRODUCT (A SEAT CUSHION THAT CAN HELP ALLEVIATE BACK PAIN) WITH HIGH HOPES TO HELP ME SUPPORT MY BACK SINCE I WORK IN FRONT OF A COMPUTER ALL DAY ON A USUAL WORKING DAY. THE CLAIMS THAT THE SELLERS GENERATED A LOT OF HOPES NOT JUST FOR ME BUT FOR MANY BACKERS WHICH IS EVIDENT FROM THE COMMENTS THE BACKERS HAVE BEEN POSTING. EVEN THOUGH IT WAS THE PEAK OF COVID SITUATION AND I WAS STUCK IN (B)(6) DUE TO FLIGHT CANCELLATIONS, I STILL BELIEVED IN THE PRODUCT. THAT IS THE REASON I PLACED AN ORDER FOR NOT JUST ONE BUT TWO OF THESE. I WAS HOPING IT WOULD HELP MY WIFE AS WELL. I HAD IT DELIVERED TO A FRIEND'S ADDRESS BECAUSE I WAS NOT IN THE US. I DID ALL THIS ONLY BECAUSE I BELIEVED IN THE PRODUCT AND I WAS CONFIDENT THAT THIS COULD BE THE ANSWER TO NUMEROUS PEOPLE LIKE ME WHO HAVE TO SIT FOR HOURS TOGETHER. AS SOON AS I REACHED THE US AND FINISHED MY QUARANTINE PERIOD, I VISITED MY FRIEND WHO LIVES ABOUT 60 MILES AWAY TO PICK UP THE CUSHIONS AND STARTED USING MINE IMMEDIATELY. IN A COUPLE OF DAYS I STARTED FEELING WEIRD IN THE LOW BACK AREA BUT I THOUGHT IT MIGHT JUST BE MY BODY ADJUSTING TO THE CUSHION AND WANTED TO CONTINUE USING IT FOR A FEW MORE DAYS TO SEE HOW IT WORKS. ALAS, THAT WAS A MAJOR MISTAKE. IN JUST A COUPLE OF WEEKS MY LOWER BACK BECAME SO WEAK THAT I HAD TO VISIT A DOCTOR, GET AN MRI, START TAKING PAIN KILLERS, AND GO THROUGH PHYSICAL THERAPY; I IMMEDIATELY HAD MY WIFE STOP USING IT AS WELL BECAUSE SHE IS PREGNANT AND I DON'T EVEN WANT TO IMAGINE WHAT WOULD HAPPEN IF SHE CONTINUES USING IT LIKE ME. I WAS GOING TO LET IT GO BUT I WAS NOT COMFORTABLE WITH THE FACT THAT THE SELLER CAN GET AWAY WITH SELLING PRODUCTS LIKE THIS WHICH CAN HAVE MAJOR HEALTH IMPLICATIONS FOR MASSES. HENCE, I REACHED OUT TO THE SELLER THROUGH (B)(6) MESSAGING SECTION BUT I RECEIVED NO RESPONSE. THE NEXT ALTERNATIVE I SAW WAS TO GO THROUGH A CREDIT CARD DISPUTE. HOWEVER, (B)(6) IS TRYING TO PROTECT ITS SELLER AND PROVIDING BLANKET TERMS AND CONDITIONS AS A JUSTIFICATION OF WHY THEY ARE NOT GOING TO HELP ME HERE. I HAVE ALSO DIRECTLY REACHING OUT TO (B)(6), AND THEY HAVEN'T RESPONDED EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134318 BALANCEON PROTECTOR, SKIN PESSURE FMP BULLSONE CO., LTD.
    1134319 BALANCEON PROTECTOR, SKIN PESSURE FMP BULLSONE CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other