HCC-882.50 OR UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-19 for HCC-882.50 OR UNKNOWN manufactured by Unk.

Event Text Entries

[3265405] Full report submitted to (b)(4) at fcc. Initial inquiries were made to (b)(4). The concern is acute reversible symptoms are resulting from a device using the electromagnetic spectrum regulated by the fcc. The danger with the symptoms produced depend on the frequency used which can vary from no effect, mild effect, pain, or ablation of tissue. Most of the symptoms are reversible and would be associated with interference with quality of life. However, pain and pressure thresholds can be reached which cause indirect adverse effects resulting in public health dangers such as injury, fraud, organizational change to game the system. For example each part of the body would need to be addressed separately. If an electromagnetic signal is transmitted to the head the pressure and ear pain if exceeding threshold would result in tinnitus and nausea interfering with capacity to drive if symptom onset is in a car. The result would be injury or accident. Another example is pain directed to a limb or vessel which exceeds threshold and results in a vasovagal response with subsequent loss of balance resulting in injury. See fcc report as they should have additional data to locate the signal and device. The concern is how widespread is dissemination of equipment and software by inappropriately trained consumers or providers as misuse is associated with lack of informed consent resulting in financial fraud, gaming the system through organizational change, or acute reversible symptoms resulting in near injury or quality of life issues. An undisclosed financial motivation is associated with the use of the technology resulting in risk of morbidity and morality. I have a concept piece which describes the widespread use of the technology in different disciplines. Some use is appropriate. The concern would be the misuse by consumers, technicians or unlicensed providers without appropriate knowledge. Also, the device may be inappropriately classified as a 2 way signal having informed consent and the misuse is it is perceived as a one way signal without the control to stop the signal as informed consent isn't routinely obtained face to face. I am happy to send to you with a list of references based on my own exploration of the problem. The nih has updated the consent on the subject on their website. The challenge with the technology is this case was associated with medicare billing fraud and it is being used manipulatively without direct face to face consent. Is the fcc able to document a signal at the locations? Owner of device is using new satellite, wireless or electromagnetic spectrum to transmit without informed consent.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5029866
MDR Report Key3072700
Date Received2013-04-19
Date of Report2012-08-10
Date Added to Maude2013-04-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHCC-882.50 OR UNKNOWN
Generic NameBIOFEEDBACK OR NEUROFEEDBACK
Product CodeHCC
Date Received2013-04-19
OperatorOTHER
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2013-04-19

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