Report if admission to the hospital or a longer hospital stay results because of the adverse event. Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child. Report if you suspect that the use of a medical product resulted in a condition that required medical or surgical intervention to prevent permanent impairment or damage to a patient. Problems with product quality may occur during manufacturing, shipping, or storage. They include product contamination defective parts poor packaging or product mix-up questionable stability device malfunctions labeling concerns With drugs, the pharmacist is often the first to recognize a product quality problem.
Nurses are often the first to recognize a problem with a medical device.
These suspicions should be reported to FDA through MedWatch . From 1985 until January 2000, FDA received 127,770 adverse reaction reports for silicone gel-filled breast implants. During the same time period, FDA received 65,720 adverse reaction reports for saline-filled implants. There were 1712 additional summary reported problems in which the type of implant was unknown. As of January 2000, FDA received 123 reports of deaths reportedly related to breast implants.