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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAGNAWAVE SOL PRO MAGNAWAVE; DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT

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MAGNAWAVE SOL PRO MAGNAWAVE; DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT Back to Search Results
Lot Number SP51002
Health Effect - Clinical Codes Diarrhea (1811); Headache (1880); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Blurred Vision (2137); Dizziness (2194); Malaise (2359); Sensitivity of Teeth (2427); Confusion/ Disorientation (2553); Ear Pain (4812)
Type of Reportable Event Serious Injury
Event or Problem Description
I order this machine back in (b)(6) 2023.It took over a month to get to me as they were building it.Once i had the machine i took the courses to be certified as a practioner.They teach you about how to use it on animals (horse, small animals and livestock).They tell you that you can use it on humans too but do not teach about it.The second month of having the machine i built a clientele and was using it a lot during the weeks.Some days i would do 4 to 7 horses in a day.During the courses they teach that you can only use it on horses a total of 40mins then a 6 hour break before you can use it on them again.They don't teach why though.I had in the back of my mind a question of what happens to us the practioners using it for more than that a day? every time i had used the machine, i noticed my teeth would hurt like a sensitivity and i would get a headache after.Well one week closer to my last week of using it my 14 year old daughter starting complaining about sharp ear pain and pressure that moved behind her eyes, then her blood pressure dropped.This was all while she was holding a horse for me while i was using it.She never touched the machine and was just close to it.I quit using her to help because it was clearly affecting her.My last week of use i started noticing how nauseous i would feel after using it and the life being sucked out of me on top of the teeth sensitivity and diarrhea.I started to drink a lot more water thinking it was still detoxing me.My last day i decided to stay further away from the machine once i turned it on.Within 5 mins i had extreme pressure and stabbing pain behind my ears.My session was a short 20 min thankfully and once i left everything started to increase in symptoms.Extreme head pressure, nausea, blurred vision, dizziness, diarrhea and confusion.I was then sick like this the rest of the day.Upon this sickness i started researching pemf over use and what it can cause.I was having negative side effects from pro longed use of the machine.I started contacting the company which gave me a run around.I then posted on their group facebook page to ask a question if anyone was having negative side effects from the machine.They deleted my post and sent a feedback that i need to take an active charcoal binding agent with electrolytes.I do have this screenshot of the post and feed back.Well, activated charcoal binding agent is for drawing out poison.That was a red flag to me, am i poisoning myself and my family? no other explanation.Charcoal is also for people who use pharmaceuticals.I haven't used prescription drugs or anything in over 13 years.I shouldn't be taking that.I wasn't satisfied with my answer nor with the fact i invested into this machine for my business so i kept bugging them.I finally received a phone call from (b)(4) of magnawave (b)(4).In the beginning of our conversation she said she had never heard such a thing happening to anyone.I kept asking questions and poking and prodding.She then began to tell me that this has only happened to 3-4 people out of the 8,000 machines out there and i would no longer be able to be around the machine much less 5htz of emf.She also told me it was temporary and would go away.Contradictions for sure! if it will go away then why cant i be near the machine ever again? she then proceeded to tell me that a man she knows has to be completely off grid because he can no longer be near emf (electromagnetic fields), he was hypersensitive to it.I started researching and that's exactly what i had going on! i am currently hypersensitive to electromagnetic fields.It has me confined to my house and the most relief i get is when i am in my yard sitting in the grass.I can't even go to town or church without my head feeling like its about to exploded with extreme nausea and blurred vision.Now that i can't be around the machine, i asked them what to do, they said sell it.This is also financed plus i cannot sell something to someone that has caused this to me.I got them to offered to buy it back.I currently still have the machine as i can't go into the city to send it back.I am waiting for one of my family members to have the time to do so.This company knows way more about this than they are letting out.There needs to be a warning or more education taught to the practioners on how to protect from overuse of the machine.They claim this machine is in the process of being approved by the fda as well.This needs a warning! it also made some of my clients sick and in pain after using it briefly.This is not okay and ruining my life and business.I can't go anywhere around emf without instant symptoms.Cell phones are awful as well as steel buildings.I can drive around and tell you exactly where emf start and stop.If i am in them too long, i can't kick the symptoms, or you can say sickness.The symptoms also intensify the longer i am in emf.Going to the doctor is even very hard as i get really sick.They drew my blood, and it was outstanding.(b)(4) of the company magnawave also suggested that i may have an underlying health issue the machine is drawing out.No, the doctor said with the test i was very healthy.I am currently waiting to see a neurologist in hopes to find out more.I would also like to please remain anonymous in this report.
 
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Brand Name
SOL PRO MAGNAWAVE
Common Device Name
DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT
Manufacturer (Section D)
MAGNAWAVE
2208 plantside dr
louisville KY 40299
MDR Report Key17836521
Report NumberMW5146248
Device Sequence Number3180448
Product Code ILX
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 09/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberSP51002
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/27/2023
Patient Sequence Number1
Patient SexUnknown
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