Medical Device Data System
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §880.6310 (General Hospital panel).
FDA MAUDE casebook
openFDA event book Medical Device Data System LIGHT-BOOK · MAUDE
#410 of 1000 · 2,981 reports · 2011–2026
- BOOK 2,981 reports
- RANK #410 of 1000
- DEATH 10 death-typed
- INJ 49 injury-typed
- MALF 2,848 malfunction
- SPAN 2011–2026
- PEAK 2023: 1,249
- PHOTO Latex Patient Examina…
Nearest event-volume peer: Latex Patient Examination Glove (11 report gap)
Medical Device Data System sits #410 of 1000 among tracked device types with 2,981 MAUDE reports spanning 2011–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Medical Device Data System carries 95.5% MALFUNCTION-coded reports, 30.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
- INJ 1.6% corpus 30.3% · below corpus mean (-28.6 pp)
- MALF 95.5% corpus 64.8% · above corpus mean (+30.7 pp)
Lead product-problem code Computer Software Problem is 45% of coded problems · Lead manufacturer MEDTRONIC MINIMED accounts for 93% of manufacturer-tagged reports · Top event location is 80% of location-tagged rows .
Medical Device Data System in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Interoperable…
Interoperable Automated Glycemic Controller
3,009 reports
- Prosthesis
Prosthesis, Tracheal, Expandable
3,009 reports
- Latex Patient…
Latex Patient Examination Glove
2,992 reports
- Medical Devic… (this)
Medical Device Data System
2,981 reports
- System
System, Photopheresis, Extracorporeal
2,966 reports
- Light Source
Light Source, Fiberoptic, Routine
2,959 reports
What this shows Medical Device Data System carries 2,981 MAUDE reports, ranked #410 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports fell to 400 in 2025, down from an average of 902 in the two years before.
Related Entities for Medical Device Data System
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Medical Device Data System: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (2,981 here).
Similar death-typed counts
Nearest other device types by death-typed report count (10 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Medical Device Data System are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Medical Device Data System; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.