2026 data FDA MAUDE openFDA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

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 Prostate-Specific Antigen For Management Of… LIGHT-BOOK · MAUDE

#785 of 1000 · 650 reports · 1996–2026

  • BOOK 650 reports
  • RANK #785 of 1000
  • DEATH 1 death-typed
  • INJ 69 injury-typed
  • MALF 553 malfunction
  • SPAN 1996–2026
  • PEAK 2011: 109
  • PHOTO Cannula, Catheter

Nearest event-volume peer: Cannula, Catheter (1 report gap)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers sits #785 of 1000 among tracked device types with 650 MAUDE reports spanning 1996–2026. 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 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 10.6% corpus 30.4% · below corpus mean (-19.8 pp)
  • MALF 85.1% corpus 64.5% · above corpus mean (+20.6 pp)

Lead product-problem code High Test Results is 36% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 35% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Prostate-Specific Antigen For Management Of… in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers carries 650 MAUDE reports, ranked #785 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 553 (85.1%)
Injury 69 (10.6%)
Other 27 (4.2%)
Death 1 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

563 (86.3%)
Other 75 (11.5%)
Required Intervention 7 (1.1%)
Disability 3 (0.5%)
R 2 (0.3%)
Hospitalization 2 (0.3%)

Top Product Problems

High Test Results 43
Low Test Results 38
Incorrect Measurement 19
Non Reproducible Results 10
Incorrect, Inadequate or Imprecise Result or Readings 4
Defective Device 1
Insufficient Information 1
Mechanical Jam 1
No Apparent Adverse Event 1
Nonstandard Device 1
Unable to Obtain Readings 1

Yearly Trend

96
1996: 2
97
1997: 12
98
1998: 1
99
1999: 1
00
2000: 5
01
2001: 33
02
2002: 5
05
2005: 5
06
2006: 3
07
2007: 17
08
2008: 57
09
2009: 58
10
2010: 34
11
2011: 109
12
2012: 101
13
2013: 69
14
2014: 19
15
2015: 14
16
2016: 8
17
2017: 13
18
2018: 8
19
2019: 11
20
2020: 4
21
2021: 8
22
2022: 11
23
2023: 17
24
2024: 8
25
2025: 14
26
2026: 3

Related Entities for Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Event Locations

462 (71.1%)
LABORATORY 76 (11.7%)
I 54 (8.3%)
OTHER 46 (7.1%)
INVALID DATA 5 (0.8%)
HOSPITAL 3 (0.5%)
NO INFORMATION 2 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare ROCHE DIAGNOSTICS vs BECKMAN COULTER, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Prostate-Specific Antigen For Management Of…, 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 (650 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Prostate-Specific Antigen For Management Of… 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 Prostate-Specific Antigen For Management Of…; 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.