Mouthguard, Over-The-Counter
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 MAUDE casebook
openFDA event book Mouthguard, Over-The-Counter LIGHT-BOOK · MAUDE
#662 of 1000 · 1,006 reports · 2007–2026
- BOOK 1,006 reports
- RANK #662 of 1000
- DEATH 0 death-typed
- INJ 127 injury-typed
- MALF 866 malfunction
- SPAN 2007–2026
- PEAK 2014: 776
- PHOTO Electrode
Nearest event-volume peer: Electrode, Ion Specific, Potassium (2 report gap)
Mouthguard, Over-The-Counter sits #662 of 1000 among tracked device types with 1,006 MAUDE reports spanning 2007–2026. 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 → · Similar-volume device →
Malfunction reports run above the device-type norm
Mouthguard, Over-The-Counter carries 86.1% MALFUNCTION-coded reports, 21.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 12.6% corpus 30.3% · below corpus mean (-17.7 pp)
- MALF 86.1% corpus 64.8% · above corpus mean (+21.3 pp)
Lead product-problem code Delamination is 71% of coded problems · Top event location is 84% of location-tagged rows .
Mouthguard, Over-The-Counter in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Electrode
Electrode, Ion Specific, Potassium
1,008 reports
- Mouthguard (this)
Mouthguard, Over-The-Counter
1,006 reports
- Filter
Filter, Bacterial, Breathing-Circuit
1,004 reports
- Prosthesis
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
1,004 reports
- Mixer
Mixer, Cement, For Clinical Use
998 reports
- Stent
Stent, Metallic, Expandable, Duodenal
991 reports
What this shows Mouthguard, Over-The-Counter carries 1,006 MAUDE reports, ranked #662 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (13) held close to the prior two-year average of 12.
Related Entities for Mouthguard, Over-The-Counter
Event Locations
Nationwide devices with a comparable report-volume footprint
Mouthguard, Over-The-Counter carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (1,006 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Mouthguard, Over-The-Counter 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 Mouthguard, Over-The-Counter; 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.