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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §866.6010 (Immunology panel).

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FDA MAUDE casebook

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

#801 of 1000 · 653 reports · 1996–2026

  • BOOK 653 reports
  • RANK #801 of 1000
  • DEATH 1 death-typed
  • INJ 69 injury-typed
  • MALF 556 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 #801 of 1000 among tracked device types with 653 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 →

Malfunction reports run above the device-type norm

Prostate-Specific Antigen For Management Of… carries 85.1% MALFUNCTION-coded reports, 20.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 10.6% corpus 30.3% · below corpus mean (-19.7 pp)
  • MALF 85.1% corpus 64.8% · above corpus mean (+20.3 pp)

Lead product-problem code High Test Results is 34% 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 653 MAUDE reports, ranked #801 of 1000.

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

Event Types

Malfunction 556 (85.1%)
Injury 69 (10.6%)
Other 27 (4.1%)
Death 1 (0.2%)

Patient Outcomes

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

566 (86.4%)
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 230
Low Test Results 196
Incorrect Or Inadequate Test Results 131
Incorrect, Inadequate or Imprecise Result or Readings 24
Incorrect Measurement 21
False Negative Result 14
Non Reproducible Results 10
False Positive Result 8
Device Displays Incorrect Message 5
False Reading From Device Non-Compliance 5
Calibration Problem 3
Low Readings 3
Replace 3
Defective Device 2
Device Issue 2
Fracture 2
Hole In Material 2
Improper or Incorrect Procedure or Method 2
Leak/Splash 2
Nonstandard Device 2

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: 6

Reports in 2025 (14) held close to the prior two-year average of 13.

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

Top Manufacturers

ROCHE DIAGNOSTICS 157
BECKMAN COULTER, INC. 90
BECKMAN COULTER INC. 85
ORTHO-CLINICAL DIAGNOSTICS 34
ABBOTT LABORATORIES 30
BECKMAN COULTER 30
SIEMENS HEALTHCARE DIAGNOSTICS INC. 17

Event Locations

465 (71.2%)
LABORATORY 76 (11.6%)
I 54 (8.3%)
OTHER 46 (7.0%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prostate-Specific Antigen For Management Of…: 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 (653 here).

Cannula, Catheter 654 Chair, Examination And Treatment 652 Instrument For Treatment Of Hyperhidrosis 655 Instruments, Dental Hand 656

Similar death-typed counts

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

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

Read our methodology - how this data is sourced, computed, and verified.

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.