Product Safety & Complaints

If a patient is experiencing a medical emergency, call 911 or seek immediate medical care.

Reporting Product Problems

Product quality complaints, suspected malfunctions, adverse events, or safety concerns involving the MIRARI® Cold Plasma System should be reported promptly to GVI through its designated Product Complaint / Safety channel.

Product Complaint / Safety Contact:

• Email: contact@generalvibronics.com

When reporting a product issue, please provide (where available):

• Product name and model
• Serial number, lot number, or UDI
• Description of the event or malfunction
• Date of event
• Relevant accessory information
• Purchaser/contact information

Important: Do not transmit identifiable patient health information through ordinary website forms or unsecured email unless specifically instructed to use an authorized secure process.

Nothing in this notice replaces any reporting obligation imposed by applicable law.

You may also report directly to the FDA

Healthcare professionals and consumers may report serious problems with medical devices to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program:

• MedWatch Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
• Phone: 1-800-FDA-1088 (1-800-332-1088)