Adverse Events Reporting

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.

Adverse Event (AE)

An AE is any untoward medical occurrence in a patient administered a Vericel product and which is not necessarily caused by the Vericel 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:

• Any clinically significant worsening of a pre-existing condition;
• An AE that has been associated with the discontinuation of the use of a product; and
• Any lack or loss of intended effect.

Other Safety Findings

The following are considered Other Safety Findings regardless of whether they are associated with an AE and they must be reported to Vericel:

• Use of a Vericel product while pregnant and/or breastfeeding
• Accidental or intentional medication errors or overdose of a Vericel product
• Misuse, where the Vericel product is intentionally and inappropriately used including misuse for illegal purposes
• Abuse, which is, intentional excessive use of a Vericel product
• Transmission of an infectious agent through a contaminated Vericel product
• Occupational exposure to a Vericel product (e.g., a Healthcare Provider is splashed with medicinal product while preparing an injection)
• Reports of patient “death” after exposure to a Vericel product where no other details are provided (e.g. fatal outcomes)
• Off-label use of a Vericel product (e.g. a product is intentionally used to treat a condition for which the product is not indicated). ‘

Medical Device Report (MDR)

The following are considered MDRs

• An event that reasonably suggests that the Vericel device:
• May have caused or contributed to a death or serious injury including events occurring as a result of:
  1. Failure
  2. Malfunction
  3. Improper or inadequate design
  4. Manufacture
  5. Labeling
  6. User error
• Has malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur

Product Complaints (PC)

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:

• Device that is damaged or broken
• Bent or dull needles
• Missing or illegible labeling
• Inability of customer to administer the product
• Product with an unexpected color, appearance, or particles