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Airway, Oropharyngeal, Anesthesiology

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Airway, Oropharyngeal, Anesthesiology

The FDA MAUDE database aggregates 1,570 adverse-event reports for Airway, Oropharyngeal, Anesthesiology spanning the period from 1992 through 2026. Of these, 39 are classified as death reports, 341 as injury reports, and 1,155 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 13 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Deflation Problem topping the list at 77 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 34 years of MAUDE data, with the peak single-year volume reaching 146 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 11 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

1,570
Total Reports
39
Death Reports
341
Injury Reports
1,155
Malfunctions

Event Types

Malfunction 1,155 (73.6%)
Injury 341 (21.7%)
Death 39 (2.5%)
Other 20 (1.3%)
15 (1.0%)

Patient Outcomes

1,195 (72.5%)
Required Intervention 190 (11.5%)
Hospitalization 67 (4.1%)
Other 59 (3.6%)
R 47 (2.9%)
Death 38 (2.3%)
L 16 (1.0%)
Life Threatening 12 (0.7%)
Disability 11 (0.7%)
O 6 (0.4%)
S 5 (0.3%)
D 1 (0.1%)
H 1 (0.1%)

Top Product Problems

Deflation Problem 77
Gas/Air Leak 73
Inflation Problem 58
Leak/Splash 45
Break 34
Material Separation 33
Device Operates Differently Than Expected 31
Adverse Event Without Identified Device or Use Problem 19
Detachment of Device or Device Component 15
Crack 11
Physical Resistance/Sticking 11
Contamination /Decontamination Problem 8
Deformation Due to Compressive Stress 8
Disconnection 8
Material Deformation 8
Patient Device Interaction Problem 8
Use of Device Problem 8
Material Split, Cut or Torn 7
Shelf Life Exceeded 7
Air Leak 6

Yearly Trend

92
1992: 1
94
1994: 5
95
1995: 15
96
1996: 30
97
1997: 102
98
1998: 118
99
1999: 146
00
2000: 83
01
2001: 78
02
2002: 84
03
2003: 90
04
2004: 34
05
2005: 38
06
2006: 8
07
2007: 4
08
2008: 5
09
2009: 5
10
2010: 1
11
2011: 19
12
2012: 8
13
2013: 42
14
2014: 31
15
2015: 14
16
2016: 69
17
2017: 75
18
2018: 56
19
2019: 80
20
2020: 30
21
2021: 62
22
2022: 51
23
2023: 52
24
2024: 59
25
2025: 61
26
2026: 14

Related Entities for Airway, Oropharyngeal, Anesthesiology

Event Locations

905 (57.6%)
I 326 (20.8%)
HOSPITAL 254 (16.2%)
AMBULATORY SURGICAL FACILITY 45 (2.9%)
NO INFORMATION 12 (0.8%)
INVALID DATA 8 (0.5%)
OTHER 8 (0.5%)
UNKNOWN 5 (0.3%)
OUTPATIENT TREATMENT FACILITY 4 (0.3%)
HOME 2 (0.1%)
NURSING HOME 1 (0.1%)

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.