BIOFEEDBACK DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for BIOFEEDBACK DEVICE manufactured by Ochslabs.

Event Text Entries

[39663035] On (b)(6) 2014, i went to (b)(6) to have a lens (low energy neurofeedback session). She was improperly trained, used it incorrectly and i have had severe tinnitus 24/7 ever since. I spoke to other lens practitioners and they said (b)(6) should have used only 2-3 points since i was a first time customer. (b)(6) used all 21 points. The therapists i talked to said that never should have been done. I contacted her 2 days later (see emails below). I filed in small claims court, (b)(6). The sheriff told me that (b)(6) had left the state. One therapist i contacted said she had seen several of (b)(6) clients because they were dissatisfied. I do not know the extent of their problems. I have purchased items to try to get rid of tinnitus. I contacted (b)(6) who created the lens and told them what happened. They said; "i unfortunately have no thoughts or assistance to offer you as we, a biofeedback company and not a medical company, assemble hardware and software. " however, they provide the training for the lens system. I filled out a report with the (b)(6). They said it wasn't under their jurisdiction. I have spent $(b)(6) trying to cure what (b)(6) and lens did to me. Nothing has helped. I have a record of all my communications. My initial communication after the appointment with (b)(6) follows: on (b)(6) 2014: (b)(6), this is now going on 11 days. I can barely hear out of my right ear because of the tinnitus problem created by the lens session. It is affecting my whole life. You said it may be a case of "it gets worse before it gets better". I didn't have tinnitus before the session. I paid for another lens session here in (b)(6) to see if it could correct what was done to me but it didn't help. I have also tried the salt spa which helps with cilia. That also did nothing. One thing the therapist did say was that someone as sensitive as i am should never have had 21 points worked on. They only worked on 7. I think we need to talk to see what to do about this. I do not feel i should have to pay to correct a problem that was created by this session. My phone# is (b)(6). I look forward to hearing from you. (b)(6). Original message from: >(b)(6)> to "(b)(6)> subject: re: tuesday's session, date: (b)(6) 2014 09:28:06 - 0700 - hi (b)(6) , thanks for writing with an update. I appreciate it. There are a few options with the tinnitus, first: to receive add'l treatments with lens in order to help smooth out this reaction over time. As i mentioned it can sometimes happen with the lens treatment, this may be a case of "it gets worse before it gets better". Second, is to wait it out and see if it calms itself down and goes away. Third, to schedule a session of "neuroptimal" neurofeedback, which has a calming effect on the central system. This has been known to reduce and calm down the brain after hyper stimulation from lens. I believe this is the treatment your friend received. I can refer you to a clinic called (b)(6) that would be happy to schedule with you. If you mention you came from the (b)(6), they will likely book the session for $(b)(6). Please let me know what you would like to do. Than you very much, (b)(6). On (b)(6) 2014: (b)(6), my session on tuesday was very interesting. You said it may take 24 hours to notice anything. The one thing i have noticed is tinnitus whereas, i had just a slight touch of it and it was sporadic, i now notice it in my right ear 24/7. And it is much louder than it was before. Do you know of anything i can do to reverse this? Thanks (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060633
MDR Report Key5471114
Date Received2016-02-26
Date of Report2016-02-26
Date of Event2014-08-05
Date Added to Maude2016-03-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBIOFEEDBACK DEVICE
Generic NameBIOFEEDBACK DEVICE
Product CodeHCC
Date Received2016-02-26
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOCHSLABS


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2016-02-26

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