While the purpose of medical devices is to prevent injury and save lives, mistakes continue to be made, and patients become hurt. On Tuesday, March 24, the Food and Drug Administration let out a swift warning that the EpiPen 0.03mg (epinephrine auto-injector) and EpiPen Jr 0.15mg are malfunctioning and causing serious problems that could cause death and injuries to users. EpiPens are emergency devices used to stop or delay severe allergic reactions from things like foods and insect bites in both children and adults. It’s a popular brand used by families especially because the device has become widely accepted and standard throughout U.S. schools. When in use, EpiPens are forced against the thigh of the user and meant to automatically inject the hormone epinephrine to stop a dangerous allergic reaction.
The FDA issued the warning after global biopharmaceutical companies Pfizer and Mylan spoke with medical providers reporting malfunction issues with the device could cause death or serious injuries to their patients. Pfizer is the manufacturer of the EpiPens in question, and Mylan is the company selling them. It’s estimated that EpiPens impact the lives of 15 million U.S. patients (6 million kids and 9 million adults) each year.
What is Malfunctioning?