Adverse Events and Product Complaint Reporting
Access training and resources to learn
how to report recipient adverse events and product complaints through our Event
Reporting System, FormsNet3SM.
We require transplant centers to report all qualifying recipient adverse events and/or product complaint events on all recipients of cellular product that we facilitate. FormsNet3 is a system used by the Event Reporting System (ERS) to capture information about recipient adverse events and product complaints.
FormsNet3 Qualifying Event Forms
- Recipient Adverse Event Form (Form 3001)- Used to report serious adverse events and reactions associated with cellular product infusion. In addition, report any recipient exposure and/or seroconversion to any FDA-listed relevant communicable diseases determined to be caused by or potentially caused by the product. Reporting is also required for any recipient bacteremia related to a contaminated product.
- Recipient Adverse Event Follow-up Form (Form 3003) - Used to report new information on a previously reported adverse event
- Product Complaint Form (Form 3010) - Product complaints must be reported for all cellular products that we facilitate. Qualifying product complaints include issues related to product integrity with potential impact to the safety, quality, identity, purity, or potency
All qualifying adverse events and product
complaints must be reported within 3 business days of the center becoming aware
of the incident.
Training: Recipient Adverse Event and Product Complaint Reporting
Learn about the terminology used for adverse event and product complaint reports, the events considered reportable, the elements need to file a report, and the time frame for reporting events.
Access the Training
Please log in to the NMDP/Be The Match Learning Center.
- Returning users: Log on to the Learning Center
- New users: Create an account in the Learning Center using the link on page 1 of the User Guide for Network Members (PDF).
- NMDP/Be The Match Employees: Access the Learning Center.
At least one person
from each U.S. transplant center who is involved in the adverse event or
product complaint reporting must be trained and report via the ERS. It is
strongly recommended that personnel from non-U.S. transplant centers are
trained and report via the ERS.
Event Reporting Form Samples
- Form 3001: Recipient Adverse Event Form Instructions (PDF)
- Form 3003: Recipient Adverse Event Follow-up Instructions (PDF)
- Form 3010: Product Complaint Form Instructions (PDF)
Quick Reference Guides
Background on Event Reporting System: A Simplified Process
The Event Reporting System provides a single mechanism for transplant centers to report adverse events and product complaints to the NMDP, thus simplifying the process for centers and saving centers time and resources. Investigations of adverse events and product complaints can also be initiated more quickly by Transplant Medical Services and Quality Systems because the electronic forms systematically collect all pertinent information upfront. In addition, the Event Reporting System enhances the NMDP's ability to comply with all reporting obligations we have to regulatory and funding agencies such as the FDA and HRSA.
- For FormsNet3 access, please contact Angela Hauck, Supervisor, Center Support Services, at 763-406-8451 or email@example.com.
- For recipient adverse event questions, please contact Transplant Medical Services at TMS@nmdp.org.
- For product complaint questions, please contact Quality Systems, Quality Assurance Team at firstname.lastname@example.org.