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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REBUILDER MEDICAL, INC. REBUILDER; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

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REBUILDER MEDICAL, INC. REBUILDER; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF Back to Search Results
Model Number SM 300
Device Problem Use of Device Problem (1670)
Patient Problem Pain (1994)
Event Date 04/29/2022
Event Type  Injury  
Event Description
Exacerbation of pain; i saw dr (b)(6) on (b)(6) 2022 at his office on (b)(6).I have chronic pain from peripheral neuropathy in my feet.Dr.(b)(6), i later found out is not doctor one of the first of many misrepresentations, he is a chiropractor.Dr.(b)(6) proposed a therapy involving a device rebuilder model 300 and anodyne therapy model 300 to purportedly stimulate nerve growth and reduce my pain along with supplements.It is electro therapy and infrared light.He explained that i could try this for a month and cancel if it did not work.After the first day i was in horrific pain and also found out that the supplements were made of grain alcohol.I have liver issues that were disclosed during intake.I stopped the therapy immediately and started to review the device and therapy.It is a scam and there is zero clinical evidence demonstrating any value whatsoever."dr." (b)(6) is engaged in deceptive advertising, mispresenting clinical information and defrauding people in severe pain.There are multiple warnings on the web that i later found specifically warning that this device is not intended or nor approved for peripheral neuropathy.However dr.(b)(6) is absolutely marketing in person and on his website.An fda warning letter to rebuilder medical technologies, inc.Dated july 19, 2010 from then department of health and human services and one from the ftc dated june 25th, 2020 and https://quackwatch.Org/cases/fda warning/prod/fda-warning-letters-about-products-2008/rebuilder/.I am embarrassed to say that i was defrauded, and my pain used as leverage to suspend normal critical evaluation.I am smart man; but chronic intense pain drives people to suicide and poor decisions and that fact is well documented.But even despite that, this doctor should have never prescribed a concoction of grain alcohol to someone who has liver damage that was disclosed during the history and physical interview on (b)(6) 2022.It is absolutely contraindicated, unethical, willfully negligent and obvious medical malpractice.I am like anyone else, has an expectation of trust and honesty in dealing with licensed professionals.I trust a doctor and will follow the treatment, i trust a bank not to give me counterfeit money.You implicitly trust the skill of a surgeon probably never having witnessed his skills, maybe never checked him out on the your state board of licensing and probably swallowed whatever antibiotics and pain pills prescribed without researching the manufacturer and where it came from; i did the same and i feel horrible for it, i do.But my pain should not be weaponized against me for financial gain through deceptive advertising, lies, misrepresentation and manipulative tactics and unsound and dangerous medical therapy in the hopes of relief.And i am confident that there are others who have and will be hurt by this doctor.This fake doctor is hurting people and lying to desperate patients about a free cancellation.I have reached out multiple times to return this garbage, but he will not return my calls or facilitate closure of this matter.I have already paid the first month and received a text for the next one due (b)(6).I can assure you that this is medical malpractice at its most sinister of presentations and you have contracted with this liar and thief who is actively causing harm.Fda safety report id # (b)(4).
 
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Brand Name
REBUILDER
Type of Device
STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
Manufacturer (Section D)
REBUILDER MEDICAL, INC.
MDR Report Key14576024
MDR Text Key293364231
Report NumberMW5110050
Device Sequence Number1
Product Code GZJ
UDI-Device Identifier0100866650
UDI-Public0100866650
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/30/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/31/2022
Device Model NumberSM 300
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/01/2022
Patient Sequence Number1
Patient Outcome(s) Other;
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