Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
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 Total LIGHT-BOOK · MAUDE
#879 of 1000 · 518 reports · 2007–2026
- BOOK 518 reports
- RANK #879 of 1000
- DEATH 0 death-typed
- INJ 17 injury-typed
- MALF 494 malfunction
- SPAN 2007–2026
- PEAK 2013: 89
- PHOTO System
Nearest event-volume peer: System, Test, Rheumatoid Factor (0 report gap)
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer sits #879 of 1000 among tracked device types with 518 MAUDE reports spanning 2007–2026. 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
Total carries 95.4% MALFUNCTION-coded reports, 30.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 3.3% corpus 30.3% · below corpus mean (-27.0 pp)
- MALF 95.4% corpus 64.8% · above corpus mean (+30.5 pp)
Lead product-problem code High Test Results is 38% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 49% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .
Total in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Display
Display, Cathode-Ray Tube, Medical
525 reports
- Bur, Dental
Bur, Dental
523 reports
- Unit
Unit, X-Ray, Extraoral With Timer
521 reports
- Apparatus
Apparatus, Traction, Non-Powered
519 reports
- Total (this)
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
518 reports
- System
System, Test, Rheumatoid Factor
518 reports
What this shows Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer carries 518 MAUDE reports, ranked #879 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 rose to 66 in 2025, up from an average of 30 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Top Manufacturers
Event Locations
Compare ROCHE DIAGNOSTICS vs SIEMENS HEALTHCARE DIAGNOSTICS INC. →
Nationwide devices with a comparable report-volume footprint
Total carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (518 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Total 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 Total; 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.