https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program patients, instructions for use, packaging and patient education.