Vericel is committed to patient safety. Part of our mission to serve patients includes collecting, reviewing and reporting all adverse events, other safety findings, medical device reports and product complaint information associated with the use of Vericel's investigational and marketed products.
It is Vericel's policy to comply with all regulations and laws relating to reporting adverse events, other safety findings, medical device reports and product complaints.
An AE is any untoward medical occurrence in a patient administered an Amgen product and which is not necessarily caused by the Amgen product. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, combination product, or medical device, whether or not considered related to the product. This includes:
The following are considered Other Safety Findings regardless of whether they are associated with an AE and they must be reported to Vericel:
The following are considered MDRs
A PC includes any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a drug, combination product, or device after it is released for distribution to market or clinic by either Vericel or by distributors and partners for whom Vericel manufactures the material. This includes all components distributed with the drug such as packaging, drug containers, delivery system, labelling, inserts, etc. Examples include:
Epicel is widely reimbursed and included on a majority of national insurance plans.
Click here to learn more about Epicel reimbursement