Safety Watch Reporting

Welcome

Health professionals, consumers and patients can voluntarily report observed or suspected side effects (adverse events, adverse reactions), product use errors and product quality problems for medical products to ZAMRA. Voluntary reporting can help ZAMRA identify unknown risk for approved medical products. Reporting can be done through our online reporting portal or by downloading, completing and then submitting the reporting form to Safety Watch: The ZAMRA Safety Information and Adverse Event Reporting Program.

Report Online

Report Offline

Download the appropriate form from the forms listed below. The forms are in fillable pdf format. Fill in the form from your device (computer, phone or tablet) or print it out and fill it in and then scan it making sure it is clear and legible. Submit the completed form by clicking on the “Submit Report”  button below.

Note that after submitting, you cannot retrieve the report and edit it. However, you can start a new report and supply more information about the case. Please include the suspect product and a brief summary of the adverse events, medical/product use errors, or product quality issues. Other information such as the reporter and the patient characteristics (if available) should also be provided again. This may appear repetitive, but it helps the ZAMRA connect the new report with the previously submitted one.

Information You Should Report to Safety Watch

• Side effects or adverse events can include everything from skin rashes to more serious complications.
• Product quality problems such as information if a product isn’t working properly or if it has a defect.
• Product Use/Medication or Product Use Errors that can be prevented. These can be caused by various issues, including choosing the wrong product because of labels or packaging that look alike or have similar brand or generic names. Mistakes also can be caused by difficulty with a device due to hard-to-read controls or displays, which may cause you to record a test result that is not correct.
• Therapeutic failures. These problems can include when a medical product does not seem to work as well when you switch from one generic to another.