What are FDA adverse event reports for Disinfectant, Medical Devices?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Disinfectant, Medical Devices, there are 1,854 total reports including 4 death reports and 1,451 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Disinfectant, Medical Devices?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Disinfectant, Medical Devices

Name: Disinfectant, Medical Devices - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Disinfectant, Medical Devices LIGHT-BOOK · MAUDE

#502 of 1000 · 1,854 reports · 1994–2026

BOOK 1,854 reports
RANK #502 of 1000
DEATH 4 death-typed
INJ 1,451 injury-typed
MALF 196 malfunction
SPAN 1994–2026
PEAK 2021: 497
PHOTO Tubing

Nearest event-volume peer: Tubing, Pump, Cardiopulmonary Bypass (2 report gap)

Disinfectant, Medical Devices sits #502 of 1000 among tracked device types with 1,854 MAUDE reports spanning 1994–2026. 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 (-1.3 pp)
INJ 78.3% corpus 30.4% · above corpus mean (+47.8 pp)
MALF 10.6% corpus 64.5% · below corpus mean (-53.9 pp)

Lead product-problem code Insufficient Information is 32% of coded problems · Lead manufacturer ADVANCED STERILIZATION PRODUCTS accounts for 92% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Ventilator

1,864
Sterilant

1,862
Disinfectant (this)

1,854
Tubing

1,852
Radioimmunoas…

1,849
Pump

1,832

What this shows Disinfectant, Medical Devices carries 1,854 MAUDE reports, ranked #502 of 1000.

Event Types

Injury 1,451 (78.3%)

Malfunction 196 (10.6%)

Other 165 (8.9%)

38 (2.0%)

Death 4 (0.2%)

Patient Outcomes

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

Other 1,113 (55.1%)

445 (22.0%)

Required Intervention 164 (8.1%)

R 100 (5.0%)

Disability 60 (3.0%)

Hospitalization 60 (3.0%)

O 26 (1.3%)

S 24 (1.2%)

Life Threatening 10 (0.5%)

L 7 (0.3%)

H 5 (0.2%)

D 2 (0.1%)

Death 2 (0.1%)

Congenital Anomaly 1 (0.0%)

Yearly Trend

1994: 1

1995: 1

1996: 22

1997: 18

1998: 44

1999: 43

2000: 11

2001: 42

2002: 18

2003: 8

2004: 16

2005: 109

2006: 48

2007: 126

2008: 72

2009: 39

2010: 18

2011: 40

2012: 37

2013: 31

2014: 18

2015: 15

2016: 13

2017: 6

2018: 15

2019: 12

2020: 73

2021: 497

2022: 171

2023: 95

2024: 116

2025: 70

2026: 9

Top Manufacturers

ADVANCED STERILIZATION PRODUCTS 234

CAREFUSION, INC 19

Event Locations

1,289 (69.5%)

I 309 (16.7%)

NO INFORMATION 156 (8.4%)

HOSPITAL 53 (2.9%)

OUTPATIENT TREATMENT FACILITY 19 (1.0%)

INVALID DATA 12 (0.6%)

OTHER 7 (0.4%)

OUTPATIENT DIAGNOSTIC FACILITY 3 (0.2%)

UNKNOWN 3 (0.2%)

HOME 1 (0.1%)

NOT APPLICABLE 1 (0.1%)

NURSING HOME 1 (0.1%)

Compare ADVANCED STERILIZATION PRODUCTS vs CAREFUSION, INC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Disinfectant, Medical Devices, 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 (1,854 here).

Tubing, Pump, Cardiopulmonary Bypass 1,852 Radioimmunoassay, Free Thyroxine 1,849 Sterilant, Medical Devices 1,862 Ventilator, Emergency, Manual 1,864

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Catheter, Urethral 4 Drill, Surgical, Ent Including Handpiece 4 Electrode 4 Electrode, Ion Specific, Potassium 4

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

Disclaimer: MAUDE figures for Disinfectant, Medical Devices 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 Disinfectant, Medical Devices; 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.

Disinfectant, Medical Devices

Event-type mix vs corpus