2025 data FDA MAUDE openFDA FDA Class I

Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer

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 §872.3410 (Dental panel).

FDA MAUDE casebook

openFDA event book Adhesive LIGHT-BOOK · MAUDE

#542 of 1000 · 1,663 reports · 1998–2025

  • BOOK 1,663 reports
  • RANK #542 of 1000
  • DEATH 35 death-typed
  • INJ 479 injury-typed
  • MALF 20 malfunction
  • SPAN 1998–2025
  • PEAK 2009: 610
  • PHOTO Laryngoscope

Nearest event-volume peer: Laryngoscope, Endoscope (1 report gap)

Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer sits #542 of 1000 among tracked device types with 1,663 MAUDE reports spanning 1998–2025. 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 sit below the device-type norm

Adhesive carries 1.2% MALFUNCTION-coded reports, 63.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.1% corpus 1.5% · above corpus mean (+0.6 pp)
  • INJ 28.8% corpus 30.3% · below corpus mean (-1.5 pp)
  • MALF 1.2% corpus 64.8% · below corpus mean (-63.6 pp)

Lead product-problem code Patient-Device Incompatibility is 37% of coded problems · Top event location is 98% of location-tagged rows .

Adhesive in the event-volume neighbourhood

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

reports

What this shows Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer carries 1,663 MAUDE reports, ranked #542 of 1000.

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

Event Types

Other 1,102 (66.3%)
Injury 479 (28.8%)
Death 35 (2.1%)
27 (1.6%)
Malfunction 20 (1.2%)

Patient Outcomes

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

Other 1,111 (54.2%)
S 282 (13.8%)
Hospitalization 204 (10.0%)
Disability 147 (7.2%)
107 (5.2%)
O 50 (2.4%)
Required Intervention 47 (2.3%)
R 41 (2.0%)
Death 34 (1.7%)
Life Threatening 14 (0.7%)
L 11 (0.5%)
H 2 (0.1%)

Top Product Problems

Patient-Device Incompatibility 613
Insufficient Device Problem Information 578
Unknown (for use when the device problem is not known) 305
Improper or Incorrect Procedure or Method 40
Adverse Event Without Identified Device or Use Problem 34
Device Operates Differently Than Expected 18
Use of Device Problem 16
Loss of or Failure to Bond 12
Appropriate Device Problem Term/Code Not Available 9
Failure To Adhere Or Bond 8
Human-Device Interface Problem 7
Migration or Expulsion of Device 6
Leak/Splash 5
Product Quality Problem 5
Difficult to Remove 4
Loose 4
Device Slipped 3
Detachment of Device or Device Component 2
Labelling, Instructions for Use or Training Problem 2
Material Deformation 2

Yearly Trend

98
1998: 1
04
2004: 6
05
2005: 3
06
2006: 4
07
2007: 18
08
2008: 31
09
2009: 610
10
2010: 513
11
2011: 271
12
2012: 74
13
2013: 35
14
2014: 30
15
2015: 47
16
2016: 1
17
2017: 3
18
2018: 2
19
2019: 3
20
2020: 5
22
2022: 3
24
2024: 2
25
2025: 1

Reports fell to 2 in 2024, down from an average of 4 in the two years before.

Related Entities for Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer

Event Locations

1,630 (98.0%)
I 19 (1.1%)
NO INFORMATION 14 (0.8%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Adhesive: 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 (1,663 here).

Similar death-typed counts

Nearest other device types by death-typed report count (35 here), distinct from the volume row.

Disclaimer: MAUDE figures for Adhesive 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 Adhesive; 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.