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2025 data FDA MAUDE openFDA FDA Class I

Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt

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 §872.3490 (Dental panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Adhesive LIGHT-BOOK · MAUDE

#746 of 1000 · 773 reports · 1998–2025

  • BOOK 773 reports
  • RANK #746 of 1000
  • DEATH 12 death-typed
  • INJ 191 injury-typed
  • MALF 14 malfunction
  • SPAN 1998–2025
  • PEAK 2011: 204
  • PHOTO Electrosurgical

Nearest event-volume peer: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (1 report gap)

Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt sits #746 of 1000 among tracked device types with 773 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 1.8% MALFUNCTION-coded reports, 63.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.6% corpus 1.5% · near corpus mean (+0.0 pp)
  • INJ 24.7% corpus 30.3% · below corpus mean (-5.6 pp)
  • MALF 1.8% corpus 64.8% · below corpus mean (-63.0 pp)

Lead product-problem code Insufficient Device Problem Information is 42% of coded problems · Top event location is 93% 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, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt carries 773 MAUDE reports, ranked #746 of 1000.

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

Event Types

Other 490 (63.4%)
Injury 191 (24.7%)
66 (8.5%)
Malfunction 14 (1.8%)
Death 12 (1.6%)

Patient Outcomes

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

Disability 371 (39.3%)
Other 203 (21.5%)
91 (9.6%)
S 83 (8.8%)
Hospitalization 81 (8.6%)
O 41 (4.3%)
R 34 (3.6%)
Required Intervention 14 (1.5%)
Death 12 (1.3%)
H 5 (0.5%)
L 5 (0.5%)
Life Threatening 3 (0.3%)
D 1 (0.1%)

Top Product Problems

Insufficient Device Problem Information 331
Patient-Device Incompatibility 187
Adverse Event Without Identified Device or Use Problem 101
Unknown (for use when the device problem is not known) 51
Appropriate Device Problem Term/Code Not Available 25
Improper or Incorrect Procedure or Method 20
Device Operates Differently Than Expected 15
Product Quality Problem 10
Use of Device Problem 7
Loose 5
Device Dislodged or Dislocated 4
Difficult to Remove 4
Loss of or Failure to Bond 4
Material Integrity Problem 3
Reaction 3
Adhesive Too Strong 2
Device Markings/Labelling Problem 2
Device, removal of (non-implant) 2
Nonstandard Device 2
Sticking 2

Yearly Trend

98
1998: 3
00
2000: 2
01
2001: 1
02
2002: 1
04
2004: 9
05
2005: 32
06
2006: 20
07
2007: 5
08
2008: 1
09
2009: 2
10
2010: 197
11
2011: 204
12
2012: 107
13
2013: 24
14
2014: 8
15
2015: 79
16
2016: 11
17
2017: 9
18
2018: 1
19
2019: 6
20
2020: 1
22
2022: 1
23
2023: 5
24
2024: 29
25
2025: 15

Reports rose to 29 in 2024, up from an average of 3 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt

Event Locations

718 (92.9%)
I 38 (4.9%)
NO INFORMATION 12 (1.6%)
HOME 3 (0.4%)
NOT APPLICABLE 1 (0.1%)
UNKNOWN 1 (0.1%)

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 (773 here).

Electrosurgical 772 Cleanser, Denture, Over The Counter 776 Surgeon'S Gloves 770 Surgical Device 770

Similar death-typed counts

Nearest other device types by death-typed report count (12 here), distinct from the volume row.

Catheter, Retention Type, Balloon 12 Digital Breast Tomosynthesis 12 Excimer Laser System 12 Implantable Transprostatic Tissue Retractor… 12

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

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.