BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURE ENRICHMENT PURERELIEF¿ XL HEATING PAD - LCD CONTROLLER

    MDR report key: 15885993 · Received November 29, 2022

    Report

    Report Number
    MW5113530
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    November 26, 2022
    Report Date
    November 27, 2022
    Manufacturer
    BEAR DOWN BRANDS, LLC.
    Product Code
    IRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHILE USING A PURE ENRICHMENT HEATING PAD ON MY SHOULDER ON THE MORNING OF (B)(6) 2022, THE HEATING PAD JUST GAVE ME A FULL BODY, SEIZURE INDUCING SHOCK OF ELECTRICITY. THE SHOCK FROM THIS HEATING PAD WAS SO BAD THAT I WAS PARALYZED IN THE FETAL POSITION ON THE FLOOR FOR HALF AN HOUR AFTER THE ELECTRIC SHOCK AND IT TOOK AN ADDITIONAL 3+ HOURS TO RECOVER FULL CONTROL OVER MY MUSCLES. I HAVE NO IDEA HOW IT HAPPENED BECAUSE I HAD FALLEN BACK ASLEEP. I KNOW! I KNOW! DO NOT SLEEP WITH A HEATING PAD ON. I'M A FLAWED MAN. I BROKE THE FIRST RULE BUT, REGARDLESS, I DID NOT EXPECT THAT NEAR DEATH ELECTRIC SHOCK WAS A POSSIBLE OUTCOME OF BREAKING THAT RULE. WHAT I DO REMEMBER IS THAT I AWOKE HAVING FULL BODY MUSCLE CONVULSIONS AND THAT I ROLLED ONTO THE FLOOR WHERE THE HEATING PAD LOST CONTACT WITH MY BODY. I LAY ON THE FLOOR SWEATING AND DISORIENTATED WITH MY MUSCLES IN SPASM WHILE I TRIED TO THINK CLEARLY AND BREATHE RHYTHMICALLY AGAIN. THIRTY MINUTES PASSED BEFORE I COULD CONTROL MY LEGS ENOUGH TO STAND BACK UP. THREE HOURS PASSED BEFORE I COULD SMOOTHLY CONTROL ALL OF MY BODY'S MUSCLES. I WAS PHYSICALLY SORE, AS IF I HAD BEEN BEATEN BY GORILLAS WITH CLUBS, ALL DAY AFTER THAT TIME. I DID NOT FULLY FEEL "NORMAL" UNTIL THE NEXT DAY AFTER A FULL NIGHT'S SLEEP. YET, MY FULL BACK MUSCLES AND MY CALF MUSCLES ARE STILL SORE 36 HOURS LATER. I DO NOT THINK THAT IT IS AN EXAGGERATION TO REPORT THAT THIS EVENT WAS NEAR DEATH. THIS HEATING PAD LOOKS EXACTLY LIKE THE RECALLED 24 INCH GRAY COLORED HEATING PAD FROM WHELE BUT IT IS BRANDED BY A DIFFERENT COMPANY AND IT HAS A DIFFERENTLY SHAPED CONTROLLER. BUT, THE 24 INCH GRAY HEATING PAD ITSELF IS EXACTLY THE SAME. ALMOST CERTAINLY MANUFACTURED BY THE SAME CHINESE FACTORY AS THE WHELE HEATING PAD. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329819 PURE ENRICHMENT PURERELIEF¿ XL HEATING PAD - LCD CONTROLLER PAD, HEATING, POWERED IRT BEAR DOWN BRANDS, LLC. PEHPAD24

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Life Threatening