Adverse Event and Product Complaint Reporting

If you are reporting a product complaint, adverse event, suspected adverse reaction, quality concern, shipment issue, labeling concern, or other product-related matter involving a product distributed through ReGenEDGE Medical LLC, please contact us using one of the following methods:

When you contact us, please include (where you have the information):

• Your name, role, and contact information
• Facility or practice name
• Product name, lot or serial number, and expiration date, if available
• Date and brief description of the issue or adverse event
• Whether the patient (if any) experienced harm
• Your preferred method of contact

Please do not submit patient medical records or unnecessary patient-identifiable information through general website forms, email, SMS, or AI-enabled tools. Provide the minimum information necessary to describe the event.

Because ReGenEDGE Medical LLC does not manufacture, label, package, or ship products, the relevant vendor or manufacturer is typically responsible for product-quality investigations, recalls, returns, refunds, warranties, and regulatory reporting. ReGenEDGE may, as a courtesy concierge liaison, help facilitate communication with the vendor, but you may also need to report directly to the manufacturer or vendor in accordance with the product's labeling and your agreements with that vendor.

Healthcare professionals, patients, and consumers may also report adverse events and product quality concerns directly to the U.S. Food and Drug Administration through the FDA's MedWatch program:

• MedWatch online: fda.gov/safety/medwatch
• MedWatch forms (for example, FDA Form 3500 for healthcare professionals): fda.gov/safety/medwatch-forms

For HCT/Ps, manufacturers and other regulated entities may have specific adverse-reaction investigation and reporting obligations. See FDA guidance on investigating and reporting adverse reactions related to HCT/Ps.

Healthcare professionals are responsible for understanding and complying with their own adverse event reporting obligations, including obligations under federal and state law and under their professional licensing requirements.

Some adverse events and product issues must be reported by manufacturers, distributors, importers, or user facilities under FDA regulations. ReGenEDGE Medical LLC will cooperate with applicable mandatory reporting requirements and with vendor and manufacturer investigations.

Information you submit through this process will be handled consistent with our Privacy Policy. Where appropriate, information may be shared with the relevant vendor, manufacturer, regulator, or counsel to investigate and respond to the report.