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 1,864 total reports including 4 death reports and 1,459 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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §880.6890 (General Hospital panel).

Browse devices → Device safety hub

FDA MAUDE casebook

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

#515 of 1000 · 1,864 reports · 1994–2026

BOOK 1,864 reports
RANK #515 of 1000
DEATH 4 death-typed
INJ 1,459 injury-typed
MALF 198 malfunction
SPAN 1994–2026
PEAK 2021: 497
PHOTO Catheter

Nearest event-volume peer: Catheter, Intracardiac Mapping, High-Density Array (1 report gap)

Disinfectant, Medical Devices sits #515 of 1000 among tracked device types with 1,864 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 →

Malfunction reports sit below the device-type norm

Disinfectant, Medical Devices carries 10.6% MALFUNCTION-coded reports, 54.2pp below 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 (-1.3 pp)
INJ 78.3% corpus 30.3% · above corpus mean (+48.0 pp)
MALF 10.6% corpus 64.8% · below corpus mean (-54.2 pp)

Lead product-problem code Insufficient Device Problem Information is 23% of coded problems · Lead manufacturer ADVANCED STERILIZATION PRODUCTS accounts for 92% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Sterilant

1,870
Bed

1,867
Tubing

1,866
Disinfectant (this)

1,864
Catheter

1,863
Marker

1,851

What this shows Disinfectant, Medical Devices carries 1,864 MAUDE reports, ranked #515 of 1000.

Event Types

Injury 1,459 (78.3%)

Malfunction 198 (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 1,116 (55.0%)

449 (22.1%)

Required Intervention 164 (8.1%)

R 100 (4.9%)

Disability 61 (3.0%)

Hospitalization 61 (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: 19

Reports in 2025 (70) held close to the prior two-year average of 106.

Top Manufacturers

ADVANCED STERILIZATION PRODUCTS 234

CAREFUSION, INC 19

Event Locations

1,299 (69.7%)

I 309 (16.6%)

NO INFORMATION 156 (8.4%)

HOSPITAL 53 (2.8%)

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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Disinfectant, Medical Devices: 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 (1,864 here).

Catheter 1,863 Tubing, Pump, Cardiopulmonary Bypass 1,866 Bed 1,867 Sterilant, Medical Devices 1,870

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

Malfunction reports sit below the device-type norm