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 MAUDE casebook
openFDA event book Medical Device Data System LIGHT-BOOK · MAUDE
#396 of 1000 · 2,961 reports · 2011–2026
- BOOK 2,961 reports
- RANK #396 of 1000
- DEATH 10 death-typed
- INJ 48 injury-typed
- MALF 2,829 malfunction
- SPAN 2011–2026
- PEAK 2023: 1,249
- PHOTO Prosthesis
Nearest event-volume peer: Prosthesis, Tracheal, Expandable (2 report gap)
Medical Device Data System sits #396 of 1000 among tracked device types with 2,961 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 →
Event-type mix vs corpus
Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.
- DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
- INJ 1.6% corpus 30.4% · below corpus mean (-28.8 pp)
- MALF 95.5% corpus 64.5% · above corpus mean (+31.0 pp)
Lead product-problem code Computer Software Problem is 46% 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
- Prosthesis
Prosthesis, Elbow, Constrained, Cemented
2,976 reports
- Medical Devic… (this)
Medical Device Data System
2,961 reports
- Prosthesis
Prosthesis, Tracheal, Expandable
2,959 reports
- Agent
Agent, Injectable, Embolic
2,957 reports
- Test
Test, Hiv Detection
2,947 reports
- Test
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
2,938 reports
What this shows Medical Device Data System carries 2,961 MAUDE reports, ranked #396 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
Related Entities for Medical Device Data System
Top Manufacturers
Event Locations
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Medical Device Data System, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (2,961 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.