Adverse Event Reporting

At XPRS Medical, patient safety and product quality are our top priorities. If you experience or become aware of an adverse event involving any of our products, we strongly encourage you to report it as soon as possible. Your report helps us address potential issues quickly and ensures we maintain the highest safety and quality standards.

What is an Adverse Event? An adverse event refers to any undesirable experience or outcome associated with the use of a medical product. This may include, but is not limited to:

• Unexpected side effects or reactions

• Malfunction of a product

• Any serious health risks or harm caused by the product

How to Report an Adverse Event (Select 1 Option):

1. Online Submission: Complete our Adverse Event Reporting Form located at the bottom of this page. Please provide as much detail as possible, including the product name, SKU, and description of the event.

2. Email: Send an email to adverseevents@xprsmedical.com with the following information:

   • Reporter Information:

     • Name 
     • Email Address
     • Phone Number

   • Product Information:

     • Product Name
     • SKU/ Product Number
     • UDI Number (01) on the Barcode
     • Lot Number (10) on the Barcode

   • Adverse Event Details:

     • Date of Adverse Event
     • Description of the Event
     • Was the product used according to its intended purpose? 
       • Options: Yes, No, Unsure
     • Outcome of the Event
       • Options: No Injury, Minor Injury, Serious Injury, Death, Other
     • Details of Outcome

   • Patient Information (Optional):

     • Age
     • Gender

   • Attachments (Optional):

     • Upload Relevant Documents or Photos (File Upload, Optional)
       • Acceptable Formats: PDF, JPG, PNG, DOCX (limit 10 MB)

   • Follow-Up Consent:

     • Would you like to be contacted for follow-up?
       • Options: Yes, No
     • Preferred Method of Contact
       • Options: Email, Phone

   • Acknowledgment: "I confirm that the information provided is accurate to the best of my knowledge.

3. Phone: Call our dedicated adverse event reporting line at 1-518-691-4107 to speak directly with a representative.
4. Mail: You may also send a written report to the following address (Please allow 60 days for follow up)

• If the adverse event is life-threatening or requires immediate medical attention, contact emergency services right away before submitting a report.

• Your privacy is important to us. All reports are handled confidentially and in accordance with applicable privacy laws and regulations.

What Happens Next?

Once we receive your report, our team will:

• Acknowledge your submission within 24 hours.

• Investigate the details of the adverse event.

• Take appropriate action, which may include notifying regulatory agencies, initiating a product recall, or providing additional guidance on product usage.

• Follow up with you if additional information is needed (if contact details are provided).

Thank you for helping us maintain the highest safety and quality standards. If you have any non-urgent questions about the adverse event reporting process, please contact us at info@xprsmedical.com or through our live chat feature.