Home Legal & regulatory Adverse event reporting

— Adverse event reporting · 24/7

Tell us what happened. We'll triage within a day.

If a patient in your protocol experienced an unexpected outcome with a Element MD product — purity, stability, contamination, or any in-vitro / pre-clinical anomaly — file it here. Reports are read by a chemist and a counsel, ranked by severity, and assigned a case ID we honour. If this is an immediate human medical emergency, call 911. Element MD does not provide medical care.

Triage SLA1 business day · all cases ConfidentialityHIPAA-aligned · counsel-only FDA reportingMedWatch + FAERS coordination

File a report.

All fields marked * are required. We do not publish reports; redacted aggregates appear in the quarterly Lab Brief.

Severity grade *

G1Cosmetic — color, label, packaging G2Quality — purity or stability anomaly G3Contamination · sterility breach G4Severe · suspected harm to subject

Use your best judgement — we will re-grade on intake. G3 and G4 page the on-call chemist immediately.

Compound *

Lot / batch ID

Find this on the carton next to the COA QR code, or in your history.

Date of incident *

Date received from Element MD

What happened? *

Minimum 40 characters. The chemist will follow up by email if more detail is needed.

Storage conditions during the incident

Reconstitution medium

Reporter contact

Name *

Email *

Institution / lab

Phone

I'd like Element MD's compliance team to coordinate a parallel report to FDA MedWatch on my behalf. Recommended for G3/G4. I confirm that the information above is accurate to the best of my knowledge and that I authorize Element MD to retain this report indefinitely for safety surveillance, redacted of personal identifiers in any aggregate publication.

Case ID generated on submit · AE-2026-XXXX

Report received.

— Case ID AE-2026-0000

A chemist on the safety team will email you within one business day. Save this case ID — you'll see it in every reply. If the report was graded G3 or G4, expect a phone call within 4 hours.

View in your account → File another report

— Triage SLA

What happens next.

Every report is read by a human within one business day. Severity sets the response.

Cosmetic / packagingAcknowledge + log; investigate at next batch review.

2 days

Purity / stability anomalyPull retain sample; re-test; root-cause memo to reporter.

3–7 days

Contamination / sterilityOn-call chemist paged; quarantine batch; full investigation; full refund + replacement.

4 hours

Severe — suspected human harmCounsel-led; FDA MedWatch coordination; CSO briefed; full investigation report shared.

2 hours

— Process

Behind the scenes.

Intake

Auto-routed to safety queue. Case ID minted. Chemist + counsel notified.

Triage

Re-graded against the lot's COA, retain sample, and any prior reports.

Investigation

Pull-test of the retain; QC review; supplier notification if upstream.

Resolution

Findings + corrective action shared with reporter. Aggregated into next quarterly Lab Brief.

Regulatory

If indicated, parallel report to FDA MedWatch / FAERS via Element MD compliance.

— Emergency

Human medical emergency?

Element MD cannot provide medical care. Call 911 immediately. After the patient is stable, the on-call chemist is reachable at 1-800-ELEMENT MD-LAB ext. 9 24/7 to share batch / lot context with the treating clinician.