Adverse Event Reporting

Adverse Event Reporting

Patient safety is our priority. This page explains how to report a suspected adverse event, serious adverse reaction, serious adverse event, or product quality concern associated with the biomaterial products we supply.

EvolveBio Dental distributes dental biomaterials manufactured by CenoBiologics Ltd (the “Manufacturer”). Where appropriate, we will coordinate reporting and investigation with the Manufacturer and relevant competent authorities.

If there is an immediate risk to a patient: seek urgent clinical care first (e.g., local emergency procedures / NHS 111 / 999 as appropriate). This page is not medical advice.

1) What should be reported?

Please report as soon as possible if you become aware of any of the following:

A) Suspected adverse events / reactions in a recipient (patient)

Examples include (not exhaustive):

  • Unexpected severe inflammation, swelling, allergic-type reaction, systemic reaction, or other serious clinical deterioration temporally associated with use of the product

  • Suspected infection transmission or unexpected infection outcome where the product may be implicated

  • Hospitalisation, prolonged recovery, permanent impairment, or life-threatening outcomes (or potential for these)

B) Product quality complaints (with or without patient impact)

Examples include:

  • Packaging integrity issues, seal failure, contamination concerns

  • Labelling errors (incorrect product description, lot/batch, expiry, instructions)

  • Missing documentation or incorrect contents

  • Physical defects, unusual odour/appearance, unexpected handling characteristics

  • Cold-chain/temperature excursions (where applicable) or suspected storage compromise

C) Near misses and safety signals

Examples include:

  • A problem discovered before clinical use that could have caused harm

  • Repeated minor issues that may indicate a broader quality trend

2) Timeframes: when to report to us

To support timely investigation and any regulatory reporting requirements:

  • Urgent (serious patient harm / life-threatening / hospitalisation / suspected infection transmission): report immediately and in any event within 24 hours of becoming aware.

  • Non-urgent (quality complaint, near miss, minor event): report as soon as possible, ideally within 2 business days.

If in doubt, report—our team will help triage the issue.

3) How to report to EvolveBio Dental

Email: orders@evolvebiodental.com (preferred)
Alternative: info@evolvebiodental.com

Use the subject line:
“Adverse Event / Product Complaint – [Product Name] – [Lot/Batch Number]”

If email is not possible and it is urgent, contact us via your usual EvolveBio Dental representative and follow up by email with written details.

4) Information to include (to speed investigation)

Please include as much of the following as possible:

A) Reporter details

  • Name, role (e.g., implant dentist, periodontist, OMS), organisation/practice

  • Phone number and email

  • Practice address (or delivery site)

B) Product details (essential)

  • Product name

  • Lot/batch number and expiry date

  • Quantity supplied and quantity affected

  • Date received and storage conditions (as maintained)

  • Date and location of use (if applicable)

C) Event / complaint details (essential)

  • Date/time issue was identified

  • Description of what happened (step-by-step if helpful)

  • Whether the product was used on a patient

  • Clinical outcome and current status (if patient involved)

  • Any contributing factors (e.g., storage interruption, handling deviation, concomitant materials)

D) Evidence (helpful)

  • Photos of packaging, label, and product (if appropriate)

  • Copies of delivery note / invoice number

  • Any relevant clinical notes (please anonymise where possible)

Please do not include unnecessary patient identifiers. If patient information is necessary for safety/traceability, share the minimum required and avoid names/NHS numbers unless explicitly requested as part of an official investigation pathway.

5) Immediate actions to take (important)

If you suspect a product issue or adverse event:

  1. Prioritise patient care and follow your clinical governance procedures.

  2. Stop using the affected product(s).

  3. Quarantine remaining stock from the same lot/batch (do not discard unless instructed).

  4. Retain packaging and labels (these contain lot/batch and traceability identifiers).

  5. Document the circumstances (what happened, when, and who was involved).

  6. Report to us promptly (details above).

For urgent cases, we may ask you to preserve product and packaging for investigation and/or coordinate collection, depending on the nature of the report and safety requirements.

6) What happens after you report

Once we receive a report, we will:

  • Acknowledge receipt and may ask clarifying questions to understand the event/complaint

  • Record the report in our quality system and assess severity/urgency

  • Where appropriate, notify and coordinate with the Manufacturer (CenoBiologics Ltd) to support investigation, traceability, and corrective actions

  • Where required, support any escalation to relevant competent authorities and/or provide information needed for formal reporting pathways

  • Keep you updated on next steps, including any field safety action, recall instructions, or additional information requests

7) Regulatory reporting pathways in the UK (overview)

Reporting routes depend on product classification and context (human tissues/cells vs medical device incident pathways). As a distributor, our process is designed to support appropriate escalation and documentation.

A) Human tissues and cells (serious adverse events and reactions)

In the UK, the Human Tissue Authority (HTA) provides guidance on Serious Adverse Events and Serious Adverse Reactions (SAEARs) reporting for human application, including use of the HTA portal for reporting.
HTA guidance (Human application SAEAR reporting):
https://www.hta.gov.uk/guidance-professionals/guidance-sector/human-application/human-application-serious-adverse-event

The HTA also provides general information on human application regulation under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended):
https://www.hta.gov.uk/guidance-professionals/guidance-sector/human-application

Where SAEAR reporting is required, the relevant licensed establishment and responsible persons have duties to ensure appropriate notifications are made. We will support this process by rapidly escalating reports to the Manufacturer and maintaining required distribution records.

B) Medical device incidents (Yellow Card)

If a report relates to a medical device incident pathway, the UK MHRA Yellow Card scheme is used to report safety concerns involving medical devices (and other healthcare products).
Yellow Card portal: https://yellowcard.mhra.gov.uk/medical-devices
Yellow Card guidance for healthcare professionals: https://www.gov.uk/guidance/the-yellow-card-scheme-guidance-for-healthcare-professionals

You may report directly via Yellow Card where appropriate. We still ask that you also notify us so we can support investigation, traceability, and any manufacturer coordination.

8) Confidentiality and data protection

We will handle personal data provided in a report in line with our Privacy Policy and will only share information where necessary for investigation, traceability, compliance, and patient safety (for example, with the Manufacturer and/or competent authorities).

9) Contact details for reporting

Report to EvolveBio Dental:

  • Email (preferred): orders@evolvebiodental.com

  • Alternative: info@evolvebiodental.com

Please include: Product name + lot/batch number + brief description in your email subject line.

10) Reference links (official sources)