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Device, Anti-Snoring

Open-data reference.

FDA MAUDE adverse event data · 2003–2026

What the Data Shows About Device, Anti-Snoring

The FDA MAUDE database aggregates 2,063 adverse-event reports for Device, Anti-Snoring spanning the period from 2003 through 2026. Of these, 1 is classified as a death report, 694 as injury reports, and 1,348 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 12 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 Break topping the list at 649 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 23 years of MAUDE data, with the peak single-year volume reaching 662 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 9 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.

2,063
Total Reports
1
Death Reports
694
Injury Reports
1,348
Malfunctions

Event Types

Malfunction 1,348 (65.3%)
Injury 694 (33.6%)
13 (0.6%)
Other 7 (0.3%)
Death 1 (0.0%)

Patient Outcomes

1,406 (67.9%)
Required Intervention 430 (20.8%)
Other 185 (8.9%)
Life Threatening 20 (1.0%)
R 10 (0.5%)
Disability 9 (0.4%)
Hospitalization 4 (0.2%)
L 2 (0.1%)
O 2 (0.1%)
S 2 (0.1%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)

Top Product Problems

Break 649
Detachment of Device or Device Component 476
Adverse Event Without Identified Device or Use Problem 180
Fracture 77
Insufficient Information 59
Patient Device Interaction Problem 56
Biocompatibility 35
Crack 18
Patient-Device Incompatibility 16
Detachment Of Device Component 14
Material Integrity Problem 14
Material Separation 11
Material Fragmentation 10
Fitting Problem 7
Inadequacy of Device Shape and/or Size 6
Loose or Intermittent Connection 5
Device Operates Differently Than Expected 4
Material Split, Cut or Torn 4
Physical Resistance/Sticking 4
Use of Device Problem 4

Yearly Trend

03
2003: 2
04
2004: 2
05
2005: 3
06
2006: 3
08
2008: 1
09
2009: 11
10
2010: 7
11
2011: 69
12
2012: 445
13
2013: 72
14
2014: 49
15
2015: 28
16
2016: 18
17
2017: 32
18
2018: 61
19
2019: 56
20
2020: 24
21
2021: 49
22
2022: 40
23
2023: 50
24
2024: 185
25
2025: 662
26
2026: 194

Related Entities for Device, Anti-Snoring

Event Locations

1,611 (78.1%)
I 385 (18.7%)
HOME 27 (1.3%)
NO INFORMATION 24 (1.2%)
HOSPITAL 5 (0.2%)
UNKNOWN 4 (0.2%)
OTHER 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare PRISMATIK DENTALCRAFT, INC. vs MEDTRONIC XOMED, INC. →

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.