Adverse Event Report Form
Note: This form cannot be saved once started. Please ensure you have all required information on hand before beginning your submission.
* Indicates required field.
Reporter Information
Consent to follow up with Reporter for additional information:
Humacyte employee/agent:
Health Care Provider Information (if different from Reporter)
Consent to follow up with HCP for additional information:
Patient Information
Age
(at time of event)
(at time of event)
Height
Weight
Relevant Medical History (include pre-existing conditions, allergies, etc.)
Disease/Diagnosis
Start Date
End Date
Ongoing
Description
Disease/Diagnosis
Start Date
End Date
Ongoing
Description
Concomitant Medications (include medications taken within 30 days of event)
Medication Name
Start Date
End Date
Ongoing
Dose
Frequency
Route
Medication Name
Start Date
End Date
Ongoing
Dose
Frequency
Route
Product Information
SYMVESS
CM
Adverse Event Information
Outcome of AE:
*NOTE: Must select one serious criteria OR select Non-serious box. Cannot select both.
Is the adverse event suspected to be related to Symvess?
Description of Reaction (include details on adverse event(s), treatment(s), and all other relevant information)
Note: This box accepts text inputs only; no file uploads.
The adverse experience or product quality information you provide is shared with regulatory agencies, Humacyte Global, Inc, and business partners with whom we have contractual agreements. Any information that identifies the patient directly, such as the patient’s initials or date of birth, will be handled confidentially and in line with Humacyte’s corporate policies and local regulations. You have a right of access to your personal data which we hold about you. For further details on Humacyte’s privacy policy, please click here.