MAUDE Adverse Event Report: BEAR DOWN BRANDS, LLC. PURE ENRICHMENT PURERELIEF¿ XL HEATING PAD - LCD CONTROLLER; PAD, HEATING, POWERED

Model Number PEHPAD24

Device Problems Energy Output Problem (1431); Use of Device Problem (1670)

Patient Problems Undesired Nerve Stimulation (1980); Myalgia (2238); Diaphoresis (2452); Confusion/ Disorientation (2553); Convulsion/Seizure (4406)

Event Date 11/26/2022

Event Type  Injury  

Event Description

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).

• Brand Name: PURE ENRICHMENT PURERELIEF¿ XL HEATING PAD - LCD CONTROLLER
• Type of Device: PAD, HEATING, POWERED
• Manufacturer (Section D): BEAR DOWN BRANDS, LLC.
• MDR Report Key: 15885993
• MDR Text Key: 304635719
• Report Number: MW5113530
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PEHPAD24
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White