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Toothbrush, Powered

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FDA MAUDE adverse event data · 1995–2026

What the Data Shows About Toothbrush, Powered

The FDA MAUDE database aggregates 6,625 adverse-event reports for Toothbrush, Powered spanning the period from 1995 through 2026. Of these, 0 are classified as death reports, 612 as injury reports, and 5,874 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 4 distinct event types and 11 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 1,466 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 32 years of MAUDE data, with the peak single-year volume reaching 868 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 7 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.

6,625
Total Reports
0
Death Reports
612
Injury Reports
5,874
Malfunctions

Event Types

Malfunction 5,874 (88.7%)
Injury 612 (9.2%)
Other 103 (1.6%)
36 (0.5%)

Patient Outcomes

5,883 (88.5%)
Other 553 (8.3%)
Required Intervention 76 (1.1%)
Disability 73 (1.1%)
Hospitalization 16 (0.2%)
R 13 (0.2%)
Life Threatening 13 (0.2%)
S 10 (0.2%)
O 5 (0.1%)
H 1 (0.0%)
L 1 (0.0%)

Top Product Problems

Break 1,466
No Apparent Adverse Event 1,092
Detachment of Device or Device Component 811
Missing Value Reason 719
Detachment Of Device Component 574
Loose or Intermittent Connection 332
Insufficient Information 318
Patient Device Interaction Problem 143
Device Slipped 106
Overheating of Device 99
Mechanical Problem 94
Material Fragmentation 89
Component Falling 86
Fire 76
Material Separation 76
Device Fell 68
Electrical /Electronic Property Problem 66
Temperature Problem 64
Adverse Event Without Identified Device or Use Problem 38
Connection Problem 35

Yearly Trend

95
1995: 2
96
1996: 4
97
1997: 4
98
1998: 1
99
1999: 3
00
2000: 2
01
2001: 2
02
2002: 2
03
2003: 2
04
2004: 11
05
2005: 6
06
2006: 8
07
2007: 5
08
2008: 10
09
2009: 12
10
2010: 12
11
2011: 67
12
2012: 219
13
2013: 122
14
2014: 125
15
2015: 505
16
2016: 517
17
2017: 868
18
2018: 743
19
2019: 385
20
2020: 433
21
2021: 548
22
2022: 330
23
2023: 555
24
2024: 578
25
2025: 496
26
2026: 48

Related Entities for Toothbrush, Powered

Event Locations

I 3,494 (52.7%)
3,010 (45.4%)
NO INFORMATION 87 (1.3%)
HOME 23 (0.3%)
INVALID DATA 6 (0.1%)
UNKNOWN 4 (0.1%)
NOT APPLICABLE 1 (0.0%)

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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.