MRM/BFD NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-21 for MRM/BFD NI manufactured by Enrich Corp..

Event Text Entries

[105823] Consumer reported being concerned that the device is harmful to consumers due in large part to the manner in which it is being used. Rptr writes, "i wish to inquire about a piece of electrical med equipment which i truly think is harmful to persons due in large part to the manner in which it is being used. The device is called an mrm/bfd which stands for muscle response monitor/bio-feedback device. I came across this device last yr here in the hands of a person selling herbal preparations for the enrich co out or orem utah. " "at the time i was informed that the device was being tested and soon to have fda approval. Well i did not just fall off the farm wagon, and having worked in the field of bio-med equipment repair for a large hosp, i know what is required to market electronic med equipment that is intended to be used on humans. " "having some time go buy to give the benefit of the doubt i called enrich to make inquiry about this device. I have rec'd every evasive answers, and was told that the fda gave limited approval over five yrs ago to sell the mrm/bfd to some of their dists, and the device was no longer able to be sold. I relayed to them that the person using the device here purchased it on the spring cruise hosted by enrich early on in 1997. I guess that my main complaint is with the vagueness that is coming from enrich and the diagnostic manner in which this device is being used. It is quite easy to see, that were one to have an over supply of product and desired to move it, all one had to do is place the product specifics at the end of the test when the person being tested hand gets tired, and low and behold the need for that product shows a strong need. ""while it is not my desire to down play herbal preparations as a form of healing, since so many of the drugs in use today have a plant background ect ect i am however disturbed with this machine and the implications of its abuse. " "the person plying his herbs here" "also publishes a monthly fact sheet", in which "claims of cures are being made. " "simply put he is practicing medicine without liscense. " "please look into the fda's stand on the machine, and why enrich is being so evasive about it. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002293
MDR Report Key178212
Date Received1998-07-21
Date of Report1998-02-05
Date Added to Maude1998-07-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMRM/BFD
Generic NameMUSCLE RESPONSE MONITOR/BIO-FEEDBACK DEVICE
Product CodeHCC
Date Received1998-07-21
Model NumberNI
Catalog NumberNI
Lot NumberNI
ID NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key173286
ManufacturerENRICH CORP.
Manufacturer Address748 NORTH 1340 WEST OREM UT 84057 US


Patients

Patient NumberTreatmentOutcomeDate
10 1998-07-21

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