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2026 data FDA MAUDE openFDA FDA Class I

Floss, Dental

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 §872.6390 (Dental panel).

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FDA MAUDE casebook

openFDA event book Floss, Dental LIGHT-BOOK · MAUDE

#804 of 1000 · 649 reports · 1993–2026

  • BOOK 649 reports
  • RANK #804 of 1000
  • DEATH 0 death-typed
  • INJ 197 injury-typed
  • MALF 429 malfunction
  • SPAN 1993–2026
  • PEAK 2012: 98
  • PHOTO Aberrometer

Nearest event-volume peer: Aberrometer, Ophthalmic (0 report gap)

Floss, Dental sits #804 of 1000 among tracked device types with 649 MAUDE reports spanning 1993–2026. 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 →

Death-coded reports sit below the device-type norm

Floss, Dental carries 0.0% DEATH-coded reports, 1.5pp below 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 30.4% corpus 30.3% · near corpus mean (+0.1 pp)
  • MALF 66.1% corpus 64.8% · above corpus mean (+1.3 pp)

Lead product-problem code Break is 55% of coded problems · Top event location OTHER is 63% of location-tagged rows .

Floss, Dental in the event-volume neighbourhood

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

reports

What this shows Floss, Dental carries 649 MAUDE reports, ranked #804 of 1000.

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

Event Types

Malfunction 429 (66.1%)
Injury 197 (30.4%)
12 (1.8%)
Other 11 (1.7%)

Patient Outcomes

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

485 (72.8%)
Other 64 (9.6%)
Required Intervention 60 (9.0%)
Disability 23 (3.5%)
Life Threatening 12 (1.8%)
R 7 (1.1%)
S 6 (0.9%)
Hospitalization 5 (0.8%)
O 4 (0.6%)

Top Product Problems

Break 325
Adverse Event Without Identified Device or Use Problem 70
Detachment of Device or Device Component 42
Insufficient Device Problem Information 27
Detachment Of Device Component 22
Patient-Device Incompatibility 17
Unknown (for use when the device problem is not known) 14
Entrapment of Device 11
Device Operates Differently Than Expected 10
Difficult to Remove 6
Human-Device Interface Problem 6
Material Integrity Problem 6
Product Quality Problem 6
Sticking 6
Material Fragmentation 5
Physical Resistance/Sticking 5
Use of Device Problem 5
Appropriate Device Problem Term/Code Not Available 4
Design/structure problem 4
Device Dislodged or Dislocated 4

Yearly Trend

93
1993: 1
97
1997: 2
98
1998: 2
99
1999: 1
00
2000: 1
02
2002: 1
03
2003: 2
04
2004: 4
05
2005: 1
06
2006: 1
07
2007: 1
08
2008: 12
09
2009: 10
10
2010: 1
11
2011: 23
12
2012: 98
13
2013: 75
14
2014: 84
15
2015: 45
16
2016: 43
17
2017: 50
18
2018: 52
19
2019: 52
20
2020: 32
21
2021: 32
22
2022: 8
23
2023: 3
24
2024: 6
25
2025: 5
26
2026: 1

Reports in 2025 (5) held close to the prior two-year average of 5.

Related Entities for Floss, Dental

Event Locations

OTHER 412 (63.5%)
111 (17.1%)
I 90 (13.9%)
HOME 24 (3.7%)
NO INFORMATION 6 (0.9%)
UNKNOWN 4 (0.6%)
INVALID DATA 2 (0.3%)

Nationwide devices with a comparable report-volume footprint

Floss, Dental 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 (649 here).

Aberrometer, Ophthalmic 649 Chair, Examination And Treatment 652 Regulator, Pressure, Gas Cylinder 646 Prostate-Specific Antigen For Management Of… 653

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0 Accessories, Photographic, For Endoscope 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Floss, Dental 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 Floss, Dental; 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.