Mouthguard, Prescription
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, Prescription LIGHT-BOOK · MAUDE
#838 of 1000 · 584 reports · 1997–2026
- BOOK 584 reports
- RANK #838 of 1000
- DEATH 0 death-typed
- INJ 574 injury-typed
- MALF 7 malfunction
- SPAN 1997–2026
- PEAK 2022: 137
- PHOTO Calibrator
Nearest event-volume peer: Calibrator, Multi-Analyte Mixture (2 report gap)
Mouthguard, Prescription sits #838 of 1000 among tracked device types with 584 MAUDE reports spanning 1997–2026. 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 →
Injury-coded reports run above the device-type norm
Mouthguard, Prescription carries 98.3% INJURY-coded reports, 68.0pp 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 98.3% corpus 30.3% · above corpus mean (+68.0 pp)
- MALF 1.2% corpus 64.8% · below corpus mean (-63.6 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 61% of coded problems · Lead manufacturer PRISMATIK DENTALCRAFT, INC. accounts for 94% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .
Mouthguard, Prescription in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Chair
Chair, Adjustable, Mechanical
586 reports
- Mesh
Mesh, Surgical, Absorbable, Abdominal Hernia
586 reports
- Syringe
Syringe, Irrigating (Non Dental)
586 reports
- Mouthguard (this)
Mouthguard, Prescription
584 reports
- Calibrator
Calibrator, Multi-Analyte Mixture
582 reports
- Blood/Plasma…
Blood/Plasma Collection Device For Dna Testing
581 reports
What this shows Mouthguard, Prescription carries 584 MAUDE reports, ranked #838 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 fell to 7 in 2025, down from an average of 35 in the two years before.
Related Entities for Mouthguard, Prescription
Top Manufacturers
Event Locations
Compare PRISMATIK DENTALCRAFT, INC. vs PRISMATIK DENTALCRAFT INC. →
Nationwide devices with a comparable report-volume footprint
Mouthguard, Prescription 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 (584 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, Prescription 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, Prescription; 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.