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2026 data FDA MAUDE openFDA FDA Class I

Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

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).

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FDA MAUDE casebook

openFDA event book Carboxymethylcellulose Sodium Or Polyvinyl… LIGHT-BOOK · MAUDE

#767 of 1000 · 729 reports · 1999–2026

  • BOOK 729 reports
  • RANK #767 of 1000
  • DEATH 30 death-typed
  • INJ 659 injury-typed
  • MALF 11 malfunction
  • SPAN 1999–2026
  • PEAK 2016: 119
  • PHOTO Gastrointestinal Tube…

Nearest event-volume peer: Gastrointestinal Tubes With Enteral Specific Connectors (3 report gap)

Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium sits #767 of 1000 among tracked device types with 729 MAUDE reports spanning 1999–2026. 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 →

Malfunction reports sit below the device-type norm

Carboxymethylcellulose Sodium Or Polyvinyl… carries 1.5% MALFUNCTION-coded reports, 63.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.1% corpus 1.5% · above corpus mean (+2.6 pp)
  • INJ 90.4% corpus 30.3% · above corpus mean (+60.1 pp)
  • MALF 1.5% corpus 64.8% · below corpus mean (-63.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 39% of coded problems · Top event location I is 75% of location-tagged rows .

Carboxymethylcellulose Sodium Or Polyvinyl… in the event-volume neighbourhood

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

reports

What this shows Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium carries 729 MAUDE reports, ranked #767 of 1000.

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

Event Types

Injury 659 (90.4%)
Death 30 (4.1%)
Other 28 (3.8%)
Malfunction 11 (1.5%)
1 (0.1%)

Patient Outcomes

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

Other 606 (74.4%)
Hospitalization 60 (7.4%)
O 58 (7.1%)
Death 34 (4.2%)
R 16 (2.0%)
Required Intervention 9 (1.1%)
8 (1.0%)
H 6 (0.7%)
Life Threatening 6 (0.7%)
S 5 (0.6%)
Disability 5 (0.6%)
L 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 296
Product Quality Problem 149
Improper or Incorrect Procedure or Method 86
Insufficient Device Problem Information 64
Patient-Device Incompatibility 43
Use of Device Problem 29
Device Operates Differently Than Expected 16
Loss of or Failure to Bond 15
Appropriate Device Problem Term/Code Not Available 12
Failure To Adhere Or Bond 9
Human-Device Interface Problem 9
Unknown (for use when the device problem is not known) 9
Difficult to Remove 6
Melted 5
Device Expiration Issue 3
Manufacturing, Packaging or Shipping Problem 3
Nonstandard Device 3
Separation Failure 3
Detachment Of Device Component 2
Device Emits Odor 2

Yearly Trend

99
1999: 1
01
2001: 1
03
2003: 4
04
2004: 7
10
2010: 3
11
2011: 8
12
2012: 3
13
2013: 1
14
2014: 2
15
2015: 31
16
2016: 119
17
2017: 82
18
2018: 95
19
2019: 54
20
2020: 90
21
2021: 88
22
2022: 51
23
2023: 71
24
2024: 14
25
2025: 3
26
2026: 1

Reports fell to 3 in 2025, down from an average of 43 in the two years before.

Related Entities for Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

Event Locations

I 549 (75.3%)
178 (24.4%)
HOME 1 (0.1%)
NO INFORMATION 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Carboxymethylcellulose Sodium Or Polyvinyl…: 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 (729 here).

Gastrointestinal Tubes With Enteral Specifi… 732 Humidifier Nebulizer Kit 723 System 723 Handpiece, Direct Drive, Ac-Powered 736

Similar death-typed counts

Nearest other device types by death-typed report count (30 here), distinct from the volume row.

Apparatus, Nitric Oxide Delivery 30 Barrier, Absorbable, Adhesion 30 Bed, Patient Rotation, Powered 30 Cannula, Nasal, Oxygen 30

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

Disclaimer: MAUDE figures for Carboxymethylcellulose Sodium Or Polyvinyl… 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 Carboxymethylcellulose Sodium Or Polyvinyl…; 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.