Report a Product Complaint
or Adverse Event

Our Commitment to Safety and Compliance

At Ultra Pain Products, patient safety is our highest priority. We are committed to delivering safe, effective medical devices and maintaining full compliance with all regulatory standards. As part of this commitment, we encourage patients, caregivers, and healthcare professionals to promptly report any product concerns, complaints, or adverse events using the resources provided on this page.

Your feedback plays a critical role in helping us continuously improve our products and protect the wellbeing of every person who uses them.

What is a Product Complaint?

A product complaint refers to any concern or issue with the quality, performance, labeling, packaging, or usability of a device — whether or not it results in patient harm.

Examples of product complaints include:

The product does not function as intended
A piece of the device broke or malfunctioned
Packaging was damaged
Instructions for use were unclear

If you have experienced a problem with one of our products, but no injury or health issue occurred, please submit a Product Complaint.

What is an Adverse Event?

An adverse event is any incident in which the use of a device may have caused or contributed to a serious injury, illness, or other health-related complication.

Examples of adverse events include:

Injury during or after using the product
Worsening of a medical condition linked to product use
Allergic reactions or unexpected medical symptoms
Hospitalization or medical intervention needed after product use

If a patient was harmed, or if you suspect that a health issue was linked to the use of one of our devices, please submit an Adverse Event Report.

Reporting to the FDA

In addition to reporting directly to Ultra Pain Products, patients and healthcare professionals may also report adverse events or product problems to the U.S. Food and Drug Administration (FDA) through the MedWatch program.

To submit a report to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Report a Product Complaint or Adverse Event

Patient Name *

First

Last

Reporter Name if other than the patient

First

Last

Reporter Role if other than the patient (Patient / healthcare provider / other)

Phone Number (of whomever is filling out the form) *

Upload Reporter Number

Email Address (of whomever is filling out the form) *

Patient Age

Patient Gender

Product Name *

Model/Serial Number (if available)

Date Patient Received the Product (if known)

Date of Event

Description of the Event (what happened; include symptoms, diagnosis, etc.)

Was medical treatment required?

Was the event reported to any regulatory authorities?

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*Note: Messages sent using this form are NOT confidential. Avoid sending highly confidential information or private information through this system.