If Something Goes Wrong: Care First, Then Reporting
- Document links
- 6
- Quoted passages
- 6
- Fact-checked
- 18 September 2026
- Reviewed
- every six months
Sources on this page: www.fda.gov · reportfraud.ftc.gov · www.ftc.gov
If Something Goes Wrong: Care First, Then Reporting
If you are worried about a symptom, or it is getting worse, that is a question for a clinician, not for a web page. This page cannot tell you how serious anything is. Reporting does not treat anything and it can be done afterwards.
This page is about what comes after that. It is written for two readers: someone dealing with a problem now, and someone preparing before a procedure. If you are the first, the section immediately below is the one you need.
Care first
Regulatory reporting is a record keeping act. It does not summon help, it does not produce treatment, and it is not urgent in the way a symptom can be.
If something is wrong and you do not know how serious it is, this page cannot resolve that. A form cannot either.
The FDA’s own reporting guidance points in the same direction. Its advice to consumers who believe they have experienced a serious reaction is:
“If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor.”
Source: FDA, Reporting Serious Problems to FDA. Accessed 18 September 2026.
Take the form to your doctor. The clinical route and the reporting route run together, and the clinical one comes first.
Possible reporting routes
There is a tempting way to present this, as a clean table where each kind of problem has exactly one destination. That version is tidier than reality.
A single situation can involve more than one authority. A complication following a treatment that was marketed with claims that did not hold up touches both the product side and the advertising side. A problem involving how a clinician behaved may also involve the product they used. Choosing one route does not close the others, and you are not required to work out the correct one before acting.
Below are the routes and what each one is for.
Adverse events: first establish which situation you are in
Before the route, one question, and it changes the answer.
Was the product given to you as part of a study, or under an investigational protocol? If you were enrolled in a study, signed a research consent form, were given a registry number, or were told the product was investigational, the ordinary voluntary route is not the one to reach for first. There are then two different frameworks, depending on what the product is, and FDA describes them separately.
If it was an investigational drug or biological product, including a cellular product under an IND. FDA’s instruction is explicit:
“Adverse events involving investigational (study) drugs, such as those relating to Investigational New Drug (IND) applications, including those for cellular products administered under IND, should be reported as required in the study protocol and sent to the address and contact person listed in the study protocol. They should generally not be submitted to FDA MedWatch as voluntary reports.”
Source: FDA, “Instructions for Completing Form FDA 3500.” Accessed 18 September 2026.
If it was an investigational device study. Devices are not covered by the sentence above. They run under a separate regulation, and the reporting chain starts with the investigator rather than with you:
“The investigator must submit to the sponsor and the reviewing IRB a report of any unanticipated adverse device effect as soon as possible but no later than 10 working days after the investigator first learns of the effect.”
Source: FDA, “IDE Reports,” describing the reports required under 21 CFR 812.150. Accessed 18 September 2026.
What both have in common, and it is the practical point. Your step is the same in each: use the contact named in your consent or protocol materials and tell the study team. The investigator then follows whichever reporting rules apply, IND or IDE. Be clear about where that instruction comes from. For the drug and biological side FDA states the protocol route directly, in the sentence quoted above. For the device side the quoted rule is an obligation on the investigator, not an instruction to you; what makes contacting the study team the right first move there is that the investigator cannot report what nobody has told them, and the consent document names who to reach for exactly this purpose. What differs is the machinery behind that step, and the reason to know it exists is narrower than it looks: it is to stop you from treating the ordinary voluntary route as the default when a study is involved.
Care first still applies and comes before any of this. The reporting route is the second question, not the first.
If you are not sure which situation you are in, our page on registered studies sets out how to tell, and the consent document you signed is the place to look first. If you are not sure whether what you were given counts as a drug, a biological product or a device, that is itself a question for the study team, and it is a reasonable one to ask.
If the product was not given under a study or an investigational protocol, the route below is the one to read.
Adverse events: FDA MedWatch
MedWatch is the FDA’s reporting programme for human medical products, and the route described here is its voluntary one, which is open to patients directly.
On who can report, the program covers reports from:
“Health professionals, patients, and consumers”
On what should be reported:
“Serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products.”
Same source.
Reports can be submitted online, and consumers can use Form FDA 3500B. Health professionals can also report by telephone.
You do not need to establish that the product caused the problem. Reporting a suspicion is what the system is built to receive, and a single report is one input among many rather than a finding. What such a system can produce is a signal worth investigating, not certainty about your case.
For the field this site covers, the FDA also directs people who have been treated with regenerative medicine products and experienced adverse effects to MedWatch, and provides a direct contact address for questions about these products.
Source: FDA, Important Patient and Consumer Information About Regenerative Medicine Therapies. Accessed 18 September 2026.
Marketing and advertising: FTC
Where the issue is what you were told rather than what happened to you, the advertising side is the FTC’s area.
On how far that reaches, the FTC’s own guidance is short:
“Anyone participating in deceptive marketing is potentially liable under FTC law.”
Source: FTC, Health Products Compliance Guidance. Accessed 18 September 2026.
Read the scope as written: it attaches to participating in deceptive marketing, and it says potentially liable. It is not a rule that everyone who talks about a treatment carries responsibility for it. What it does mean is that a party who took part in making the claims can be within reach without having manufactured anything.
If what was promised and what was delivered do not match, that is the kind of matter this route exists for. What our page on marketing language does with the same guidance is show you what would have had to be behind the claim in the first place.
Practitioner conduct: the licensing board
Where the issue concerns how a licensed clinician behaved rather than the product they used, the body that licensed them is the one to ask.
What we did not open. We did not open any state licensing board’s complaint page. So this page does not tell you what a board accepts, what its process looks like, what it can do, or how long it takes. Boards differ from one another and a description written from outside them would be invention.
What this page can do is name the question and tell you where to put it: identify the licensing board or boards that apply to the practitioner and to the setting, then ask each one what it accepts and what its process is. That question is answerable by the board and by nobody else, including us.
Which board applies is not always a single board, and it is worth checking rather than assuming:
The licence may not be held where the care was given. A clinician can hold licences in more than one state. This is worth checking for whenever any part of the care happened remotely.
Different professions answer to different boards. The physician, the nurse and the technician involved in the same procedure may be licensed by separate bodies, and a complaint about one of them does not reach the others.
The facility may be licensed separately from the people in it. Where the concern is about the premises, the equipment or how the operation was run rather than about a named clinician’s conduct, the relevant body may be a facility regulator rather than a professional board.
If more than one of those describes what happened to you, more than one address may be the right one. If you do not know which board licenses a clinician, the licensing record is the place that tells you, and our page on public records covers how to find it.
What to keep
Do this early, because the ease of assembling records changes over time.
Invoices and receipts. The consent document or agreement you signed. Any written estimate. Screenshots of the marketing material as it appeared when you read it, including the date. Messages and emails. Any product label, batch or lot identifier you were given. Appointment records and dates. Notes of what you were told verbally, with the date you wrote them.
The screenshots deserve a particular mention. Web pages change. A page you remember may not read the same way later, and a copy taken at the time is a record of what you actually saw.
Reporting is not the same as a lawsuit
These are separate things and confusing them stops people from doing either.
The reporting routes above are the ones described on this page, and they are not one thing. MedWatch receives reports of serious reactions and product problems, which is safety monitoring. The FTC route is an input to consumer-protection work about how something was advertised. A licensing board oversees a practitioner’s conduct and licence. Three different objects, and none of the three is compensation.
What we are not telling you is what a report costs, whether a lawyer is needed, or what legal consequence follows from filing one. We have opened no document that settles those, and they differ by route. If any of that matters to your situation, the body you would be reporting to can tell you its own process, and a legal question belongs with someone qualified to answer it.
Whether you have a legal claim is a different question with a different process, and this page does not address it. Nothing here is legal advice.
Why reporting matters even if nothing happens to you
Individual reports are how patterns become visible.
One report of a complication is one data point and may lead nowhere. Several reports about the same product, arriving independently, can help reveal a pattern or a safety signal.
You may not hear back about your report. We have not established how replies are handled, so if none arrives, that silence is not evidence either way about what happened to the report.
Where to go from here
If you are preparing rather than reacting, the follow-up arrangements get settled in Before You Sign: The Document, the Risks, and Who Follows Up. If the problem involves care received in another country, the routes above may not apply in the same way; see Treatment Abroad: What Changes.
Before you leave this page: if anything has happened, put the documents in one folder today. Some records become harder to obtain with time, and assembling them is far easier while everything is recent.
What this does not mean
This page does not provide legal or medical advice. It does not tell you whether a product caused anything, does not estimate compensation, and does not recommend legal action. It describes where reports can be made and what to keep. If you have a serious or worsening symptom, seek appropriate medical care rather than starting with a form.
Official sources cited on this page. Every quotation above is taken from one of these. If you are reading this page because something has already happened, open the first one now.
- FDA · MedWatch, Reporting Serious Problems to FDA · accessed 18 September 2026
- FDA · Instructions for Completing Form FDA 3500 · accessed 18 September 2026 · the investigational drug and biological product instruction quoted at the top of the reporting section, which is the one that decides which route applies to you
- FDA · IDE Reports (21 CFR 812.150) · accessed 18 September 2026 · the investigational device branch, which the drug instruction above does not cover
- FDA · Important Patient and Consumer Information About Regenerative Medicine Therapies · accessed 18 September 2026
- FTC · Report Fraud · accessed 18 September 2026 · the submission surface; if you are looking up what the FTC has already done, that is a different page and it is on our public-records page
- FTC · Health Products Compliance Guidance · accessed 18 September 2026 · the scope of who can be within reach of FTC law, quoted in the marketing section
Not opened, and named so the gap is visible: no state licensing board complaint page. The licensing board section above says so where you read it and makes no claim about any board’s process.
Written and fact-checked against the sources above on 18 September 2026. No independent expert review has taken place yet, and this page says so rather than implying one. This page is reviewed every six months.