...caused or contributed to a death or serious injury; or (ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer would...or serious injury if the malfunction were to recur. (r) Medical personnel, as used in this part, means an individual who: (1) Is licensed, registered,...

...has malfunctioned and that the device or any other device marketed by the manufacturer or importer would be likely to cause or contribute to a death...or serious injury if the malfunction were to recur. (2) Receives or otherwise becomes aware of information: (i) In the medical or scientific literature,...

...a device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur. Information which leads the qualified person to determine that a device-related event...

...information which reasonably supports a conclusion that such product: "(1) has malfunctioned and the product would be likely to cause or contribute to a death...or serious injury if the malfunction were to recur; or "(2) is the subject of a liability claim or lawsuit involving an injury or death; or "(3) fails...

...has malfunctioned and that the device or any other device marketed by the manufacturer or importer would be likely to cause or contribute to a death...serious injury if the malfunction were to recur." This rule, effective November 13, 1984, is intended to assure that FDA is informed promptly of all...

...information which reasonably supports a conclusion that such product (1) has malfunctioned and the product would be likely to cause or contribute to a death...or serious injury if the malfunction were to recur; or (2) is the subject of a liability claim or lawsuit involving an injury or death; or (3) fails to...

...provides the manufacturer with information indicating that a death, serious injury, or malfunction (that would be likely to cause or contribute to a death or serious injury if it were to recur) has occurred and, in addition, the health care professional has used the words "death,"...

...injury or death or has malfunctioned in such a way that, if the malfunction were to recur, the device would be likely to cause or contribute to a death or serious injury or death. See Medical Devices for a detailed discussion of the medical device reporting regulation....

...has malfunctioned and that the device or any of the devices marketed by the manufacturer or importer would be likely to cause or contribute to a death...or serious injury if the malfunction were to recur. These reports are referred to as mandatory medical device reports. The Safe Medical Devices Act of...

...failure of the device to meet any of its performance specifications. It is reportable if the device is likely to cause or contribute to a death or serious injury if the malfunction were to occur. Medical Emergencies The most common life-threatening emergencies are listed below in decreasing...