ABSTRACT
Product complaints and reports of adverse events are unwelcome events at any company, especially if a product recall must be considered. However, these must be handled promptly and with all due diligence to prevent authentic drug- related events from negatively impacting the health and well-being of patients. This article provides an overview of the receipt, investigation and categorization of product complaints. An example of a product complaint triggered by a serious adverse event is also described. Please note that the example serious adverse event and product complaint is described in a high-level manner to protect confidentiality of the patient, hospital and company involved.