The FDA requires Medical Device Reports (MDRs) submission within 30 days of Complaint Awareness and utilizes a variety of code types to classify these MDRs. One of the code types is Patient Code, divided into Health Effect – Clinical Codes & Health Effect – Impact Codes.
For the past eight years patient death as a percentage of MDRs have been on a constant downward slope. And the trend continued in 2022. While the news is great it’s crucial to know that a patient death mentioned in an MDR does not necessarily link to the usage of the associated medical device.
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