MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-20 for MRS 2000+DESIGNO UNK manufactured by Mediconsult.
[2796462]
Mrs 2000 +: half hr. Massage on magnetic mat with probe. At completion instantaneous dizziness, body trembling, vomiting, diarrhea, tinnitus, sporadic blood pressures, pulse racing, chest palpitations, pale, clammy skin, muscle lethargy, lack of oxygen, jittery stomach, delayed memory recall, and low sodium. Assistance in ambulation still needed after 5 hours. Magnesium given as stated by technician a few hours later. No resolution of symptoms 5 hours later; then necessitated er visit. All tests negative, given referrals, still symptomatology. Doctors un-familiar with mrs 2000 +. Left with permanent and periodic symptoms from the massage. Another events on (b)(6) 2012, same symptoms test negative and again no answers. Called distributors, stated manufactured/tested in (b)(4). Spoke to distributor in (b)(4) and stated if; "given too high of a setting, the mrs 2000 would cause high bp in turn cause tinnitus". He stated would have to go back on the magnetic mat to get rid of symptoms. Device is stated to help these symptoms and also cause these symptoms. Two others in same salon experienced similar side effects. If the mrs 2000 is fda approved or registered, are they also monitoring adverse side effects and maintenance? Distributors only require 2 day or on line training, for any lay person. Audiogram done because of tinnitus. Indicated a slight hearing deficit. No hearing problem or tinnitus before this mrs 2000+. Events documented in (b)(4) 2012 letter to fda and answered via e-mail by (b)(4) inqui...
Patient Sequence No: 1, Text Type: D, B5
[3714093]
Additional info received from reporter (b)(6) 2013: i have filed twice prior, the complaint# cpt (b)(4). I am still having medical issues with no answers. My last episode to the er visit on (b)(6) 2013. Another reaction was (b)(6) 2013. This device is advertised as a "cure all" magnetic frequency breakthrough in medicine, yet when questioned further, i am now told it is no different than a rolling ball in a chair at the mall, with over a (b)(6) price tag, and further investigating thru the internet on this very device (mrs 2000+designo), it was stated that it "causes seizures" (here is the web site and statement that states this: (b)(4). The center (b)(6) 2 weeks ago young pt with epilepsy was placed on the mat with full consent of his mother (this was in (b)(6)) knowing that this could provoke a seizure due to increased electron flow through the brain. The teenage body did suffer a petit mal seizure (which was not uncommon for him anyway and was managed appropriately. ) this was a case showing that the mrs/imrs can provoke epileptic seizures. In our center epilepsy is an absolute contraindication to the use of pulsed electromagnetic field therapy. Every doctor or hospital i have been to or contacted know nothing of this magnetic frequency device i'm having issues still to date. The question is where do i go next to get help? As far as i know this device is still being used, and i'm still having medical issues. The very company that is selling this won't admit to anything or will address what this device has done to my system??? Who mandates this device? Not even the doctors i've seen know of this device or what or how to help me. Lawyers i've talked to can't help, i have exhausted my avenues of reference only to find that my experience, along with 2 others, was never reported for documentation. I have been rudely treated in my endeavors to question where are the studies and findings as to warrant this apparatus safety.
Patient Sequence No: 1, Text Type: D, B5
[16550752]
Additional info received from reporter on (b)(6) 2013: this is a re-occurrence. I have been having reactions ever since this mrs2000+ designo device was used on me in conjunction with a massage administered by a masseuse on (b)(6) 2010. My last episode to date was an er visit on (b)(6) 2013. My immediate reaction rendered an er visit, only to have similar symptomatic episodes on 3 other occasions, yet after prolonged intervals with other types of symptoms. I have been referred to different specialists only to be told they have no knowledge of this device, yet have ruled out anything medically. I have seen 4 neurologists, a cardiologist, and internists. After routine mris, eegs, cts, ekgs, x-rays, blood workups, hospital visits, and outpatient visits, i am left with negative findings, yet still lasting symptomatology from the initial (b)(6) 2010 massage treatment. I have been left with unexplained tinnitus ever since. Prior to (b)(6) 2010, i have never experienced any of these body reactions since the mrs 2000+ designo was used on me. I have tried contacting many departments trying to get help and some knowledge, as no doctor i have seen knows anything about this magnetic frequency let alone know how to help me with the side effects it has left me with. I have exhausted my avenues of reference only to find that my experience, along with two others, was never reported for documentation. The response i received from the (b)(4), was, "there are no adverse reactions to these natural vibrations nor have there ever been in 20 yrs or more, as i already mentioned in my previous email, using a low-frequency device of such minimal output is much like using a electric massage chair that you can find in many shopping malls across the country and for which there is no doctor's approval required why would there be?? " this statement from the (b)(4) appears to contradict the mrs2000's marketing advertisements, in my opinion. I also tried contacting a dr (b)(6), who was promoting this device on tv. It appears if you want to purchase this device, you get attention, and not so if you are inquiring about negative reaction. I am asking for documentation in the testing results of this apparatus in order to help my doctors in finding out exactly what kind of a reaction this can cause on the human body as in my personal case. What did this magnetic frequency do to me? I have been rudely treated in my endeavors to question where are the studies and findings as to warrant this apparatus as being safe. It is advertised as a "cure all" magnetic breakthrough in medicine, yet when questioned further, i am now told it is no different than a rolling ball in a chair at the mall. Dates of use: (b)(6) 2010. Mfr name, city and state: (b)(4). Facility incident happened: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026617 |
| MDR Report Key | 2713671 |
| Date Received | 2012-08-20 |
| Date of Report | 2012-08-20 |
| Date of Event | 2010-05-19 |
| Date Added to Maude | 2012-08-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MRS 2000+DESIGNO |
| Generic Name | MRS 2000+DESIGNO |
| Product Code | ISA |
| Date Received | 2012-08-20 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Device Expiration Date | 2000-01-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICONSULT |
| Manufacturer Address | GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2012-08-20 |