Facility must report patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare setting, including contaminants in drugs, devices, or biologics regardless of the source of contamination and/or product. Intended to capture contaminations that can be seen with the naked eye or with use of detection […]
Facilities are required to report when it receives information that reasonably suggests that a medical device has (or may have) caused or contributed to a serious injury or death of a patient or employee of the facility. The FDA receives voluntary reports on other serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that […]
