BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURE DAILY CARE NU-DERMA NATURAL DERMAL CELL ENERGY AMPLIFICATION SYSTEM

    MDR report key: 11285707 · Received February 5, 2021

    Report

    Report Number
    MW5099247
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    January 29, 2021
    Report Date
    February 5, 2021
    Manufacturer
    PURE DAILY CARE / DAJ GLOBAL PARTNERS LLC
    Product Code
    OLP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY (B)(6) YEAR OLD DAUGHTER (B)(6) WAS USING THE NU-DERMA (PURE CARE) HIGH FREQUENCY FACE ACNE WAND THAT WAS PURCHASED FROM PURE CARE DAILY COMPANY. AS SHE WAS SITTING IN FRONT OF MIRROR A LOUD WINDING NOISE CAME FROM WAND AFTER SHE PLUGGED WAND INTO WALL, SHE HAS USED THIS SEVERAL TIMES SINCE CHRISTMAS. SHE UNPLUGGED IT AND WENT TO TAKE GLASS COVER OFF TO PUT BACK INTO BOX AND IT EXPLODED IN HER HAND. OUR DAUGHTER RECEIVED NUMEROUS LARGE PIECES OF GLASS INSERTED INTO HER HAND INTO HER TENANTS AND IN BETWEEN HER FINGERS. AFTER THE EXPLOSION SHE HAD A SEVERAL LARGE HOLE IN HER HAND WITH PARTS OF THE INSIDE OF HER HAND HANGING OUT. WE CALLED 911 WHO THEN ARRIVED IMMEDIATELY TO ASSIST ME WITH STOPPING THE BLEEDING THAT WAS CONTINUOUSLY GOING. MY DAUGHTER HAD TO RECEIVE ON (B)(6) 2021 EMERGENCY HAND SURGERY AT (B)(6) HOSPITAL IN (B)(6). THE EXTENSIVE DAMAGE TO MY DAUGHTERS HAND HAS CAUSED MISSING OF SCHOOL DURING HER SENIOR YEAR NO FUNCTION OF HER PINKY FINGER AND HER FINGER NEXT TO HER PINKY. SHE HAS NO USE OF A RIGHT HAND AND CANNOT PERFORM IN SCHOOL. SHE HAS THE SURGERY AT 10:30 AM ON (B)(6) THE DOCTORS HAD TO TIE TOGETHER TENANTS THAT WERE RIPPED APART BY GLASS AND REMOVE OVER A 1 INCH PIECE OF CURVED GLASS OUT OF MY DAUGHTERS HAND. SEVERAL PIECES OF GLASS WERE REMOVED. THE INCISION THAT THEY HAD TO PERFORM WAS FROM THE BOTTOM OF THE PALM UP TO THE TOP OF HER HAND BETWEEN HER TWO FINGERS. SHE RECEIVED SEVERAL STITCHES AND HAS NO FULL RECOVERY FOR 6 TO 8 MONTHS. SHE WILL HAVE NO USE OF HER TWO FINGERS FOR AT LEAST SIX MONTHS. THERE IS NO GUARANTEE MY DAUGHTER WILL GET ANY FEELING BACK IN HER TWO FINGERS TO BE ABLE TO USE THEM. WE ARE VERY VERY UPSET AND VERY DISGUSTED. SHE SAID THE NOISE AS SOON AS SHE PLUGGED IT INTO THE WALL STARTED WINDING UP VERY LOUD SHE UNPLUGGED IT WENT TO TAKE THE GLASS OFF IN ORDER TO PUT IT BACK IN TO THE BOX TO LET HER DAD LOOK AT IT AND THE PRODUCT JUST EXPLODED. SHE WAS ON (B)(6) WITH HER FRIEND WHEN SHE WAS GOING TO PLUG THE DEVICE INTO THE WALL. HER FRIEND EVAN HEARD THE LOUD NOISE SAID "HURRY UP AND UNPLUG IT" SO SHE UNPLUGGED THE WAND AND HE WATCHED EVERYTHING ON (B)(6) AS SHE TOOK THE GLASS OFF TO PUT IT BACK IN THE BOX AND THE ENTIRE DEVICE EXPLODED IN HER HAND RIGHT IN FRONT OF HIM ON THE TELEPHONE. PLEASE HELP GET THIS OFF THE MARKET. WE HAVE CONTACTED OUR LAWYER FOR MEDICAL BILLS. WE CAN NOT AFFORD THESE BILLS DURING COVID. THANK YOU , (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER FOR REPORT MW5099247 ON 02/08/2021. SURGERY WAS ON (B)(6) 2021, THE SURGEON REMOVED A PIECE OF THE GLASS WAND WHICH WAS 1 CENTIMETER IN LENGTH. THERE WAS A SEVERED TENDON WHICH HAD TO BE TIED BACK TOGETHER. THIS PRODUCT IS NOT SAFE AND SHOULD BE PULLED OFF THE SHELF BEFORE SOMEONE ELSE GET HURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184128 PURE DAILY CARE NU-DERMA NATURAL DERMAL CELL ENERGY AMPLIFICATION SYSTEM OVER-THE-COUNTER POWERED LIGHT BASED LASER FOR ACNE OLP PURE DAILY CARE / DAJ GLOBAL PARTNERS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DA Hospitalization| S NONE UNTIL SURGERY FOR DAMAGE