2026 data FDA MAUDE openFDA FDA Class I

Toothbrush, Manual

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 Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §872.6855 (Dental panel).

FDA MAUDE casebook

openFDA event book Toothbrush, Manual LIGHT-BOOK · MAUDE

#562 of 1000 · 1,544 reports · 1994–2026

  • BOOK 1,544 reports
  • RANK #562 of 1000
  • DEATH 1 death-typed
  • INJ 250 injury-typed
  • MALF 1,218 malfunction
  • SPAN 1994–2026
  • PEAK 2022: 327
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Umbilical Artery (1 report gap)

Toothbrush, Manual sits #562 of 1000 among tracked device types with 1,544 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 → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Toothbrush, Manual carries 16.2% INJURY-coded reports, 14.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 16.2% corpus 30.3% · below corpus mean (-14.1 pp)
  • MALF 78.9% corpus 64.8% · above corpus mean (+14.1 pp)

Lead product-problem code Break is 35% of coded problems · Top event location is 51% of location-tagged rows .

Toothbrush, Manual in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Toothbrush, Manual carries 1,544 MAUDE reports, ranked #562 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,218 (78.9%)
Injury 250 (16.2%)
Other 47 (3.0%)
28 (1.8%)
Death 1 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,231 (78.3%)
Other 265 (16.8%)
Required Intervention 19 (1.2%)
R 15 (1.0%)
Hospitalization 15 (1.0%)
Life Threatening 10 (0.6%)
O 8 (0.5%)
Disability 3 (0.2%)
L 2 (0.1%)
S 2 (0.1%)
C 1 (0.1%)
H 1 (0.1%)
Death 1 (0.1%)

Top Product Problems

Break 575
Detachment of Device or Device Component 429
Product Quality Problem 133
Detachment Of Device Component 112
Material Fragmentation 84
Material Separation 77
Component Falling 32
Adverse Event Without Identified Device or Use Problem 30
Device Slipped 23
Improper or Incorrect Procedure or Method 23
Insufficient Device Problem Information 21
Device Fell 15
Entrapment of Device 15
Device Operates Differently Than Expected 13
Sticking 12
Material Disintegration 11
Material Integrity Problem 11
Patient-Device Incompatibility 10
Defective Device 8
Loose or Intermittent Connection 8

Yearly Trend

94
1994: 3
96
1996: 1
98
1998: 1
99
1999: 2
01
2001: 3
02
2002: 3
03
2003: 4
04
2004: 2
05
2005: 13
06
2006: 1
07
2007: 6
08
2008: 10
09
2009: 9
10
2010: 2
11
2011: 13
12
2012: 145
13
2013: 60
14
2014: 23
15
2015: 48
16
2016: 35
17
2017: 68
18
2018: 109
19
2019: 115
20
2020: 113
21
2021: 120
22
2022: 327
23
2023: 99
24
2024: 87
25
2025: 71
26
2026: 51

Reports in 2025 (71) held close to the prior two-year average of 93.

Related Entities for Toothbrush, Manual

Event Locations

781 (50.6%)
I 531 (34.4%)
OTHER 171 (11.1%)
NO INFORMATION 28 (1.8%)
HOME 20 (1.3%)
HOSPITAL 9 (0.6%)
INVALID DATA 2 (0.1%)
NURSING HOME 1 (0.1%)
UNKNOWN 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Toothbrush, Manual: 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 (1,544 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Toothbrush, Manual 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 Toothbrush, Manual; 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.