Medical Device Report (MDR)

An MDR is a mandatory report filed with the FDA when a medical device may have caused or contributed to a death, serious injury, or malfunction.

In the MAUDE dataset each MDR is one record, carrying nested arrays for every device and patient involved.

In this catalog it appears concretely: - coverage.granularity (MAUDE) — "One record per adverse event report, with nested arrays per device and per patient involved". - coverage.temporal (MAUDE) — "Publicly releasable MDRs from roughly 1992 to present". - estimated_size (MAUDE) — "several hundred thousand new MDRs added per year".

Conventions decide whether two sources can be joined at all. Buy one side of an analysis that ignores this convention and every reconciliation step — calendar alignment, unit conversion, entity matching — lands on your team instead of the vendor's.

The failure mode is concrete: a source can carry the Medical Device Report (MDR) label while differing from what you need on exactly the dimension that matters — One record per adverse event report, with nested arrays per device and per patient involved. Comparing two sources on that line usually settles the choice faster than any feature matrix.

You rarely have to take a vendor's word for it. 82.4% of the 1,744 datasets Datadory catalogs are free to access, and coverage.granularity (MAUDE) lets you inspect the real artifact before any budget is committed.

Treat every claim of this attribute as testable:

1. Open coverage.granularity (MAUDE) and confirm its record — "One record per adverse event report, with nested arrays per device and per patient involved" — against the files you actually receive.
2. Open coverage.temporal (MAUDE) and confirm its record — "Publicly releasable MDRs from roughly 1992 to present" — against the files you actually receive.
3. Open estimated_size (MAUDE) and confirm its record — "several hundred thousand new MDRs added per year" — against the files you actually receive.

See the term applied to real records: health-care-equipment data, health-care-supplies data.

Adjacent concepts worth reading next: - device malfunction - MAUDE - Post-market surveillance