An event that reasonably suggests that a device has or may have caused or contributed to a death or serious injury or an event about which manufacturers have received or become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury or has malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Medical Device Reportable Event
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