Adverse Events, Product Quality Complaints and Medical Information Request

CooperSurgical, Inc. is committed to serving patients in an ethical manner and in accordance with all laws and regulations related to reporting adverse events, product complaints, and other safety findings.  

To enable CooperSurgical to provide up-to-date safety and product quality information on CooperSurgical products, your support is important, whether you are a customer, patient, or healthcare professional.   By reporting side effects for CooperSurgical products, you help us to ensure the safety of our products and our patients.  Your information will also enable us to fulfill our reporting responsibilities to health authorities, which requires that we provide information on side effects with our products.

Adverse Events

An Adverse Event can be any harmful and unintended side effect related to the use of a medicine.  Examples are headache, allergic reactions, nausea, constipation, abdominal pain, insomnia and dizziness. A Serious Adverse Event is an adverse event that results in the following:

  • Fatality
  • Life-threatening symptoms
  • Required or prolonged hospitalization
  • Disability or incapacity
  • A congenital anomaly or birth defect
  • A medically serious condition
Product Quality Complaints

 A Product Quality complaint 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 CooperSurgical or by distributors and partners for whom CooperSurgical 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
  • Missing or illegible labeling
  • Product with an unexpected color, appearance, or particles
Medical Information Requests

A Medical Information Request is a question that relates to medical information that cannot be found in the FDA approved label of a product. These may be initiated by persons or entities that are completely independent of CooperSurgical and may include HCPs, health care organizations, members of the academic community and formulary committees as well as consumers such as patients and caregivers. 

How to Report?

If your report involves PARAGARD©

Please submit all Adverse Events, Product Quality Complaints and Medical Information Requests by calling 1-877-PARAGARD –option 1, then option 5.

If your report involves a CooperSurgical product other than PARAGARD©

Please submit all Adverse Events, Product Quality Complaints and Medical Information Requests by emailing productsurveillance@coopersurgical.com.