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Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

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FDA MAUDE adverse event data · 1999–2025

What the Data Shows About Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

The FDA MAUDE database aggregates 728 adverse-event reports for Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium spanning the period from 1999 through 2025. Of these, 30 are classified as death reports, 658 as injury reports, and 11 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 5 distinct event types and 12 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 Adverse Event Without Identified Device or Use Problem topping the list at 282 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 20 years of MAUDE data, with the peak single-year volume reaching 119 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 4 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.

728
Total Reports
30
Death Reports
658
Injury Reports
11
Malfunctions

Event Types

Injury 658 (90.4%)
Death 30 (4.1%)
Other 28 (3.8%)
Malfunction 11 (1.5%)
1 (0.1%)

Patient Outcomes

Other 605 (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 282
Product Quality Problem 148
Improper or Incorrect Procedure or Method 77
Insufficient Information 59
Patient-Device Incompatibility 39
Use of Device Problem 28
Device Operates Differently Than Expected 16
Loss of or Failure to Bond 14
Appropriate Term/Code Not Available 9
Failure To Adhere Or Bond 9
Difficult to Remove 6
Device Expiration Issue 3
Manufacturing, Packaging or Shipping Problem 3
Separation Failure 3
Detachment Of Device Component 2
Device Emits Odor 2
Expiration Date Error 2
Nonstandard Device 2
Application Program Problem: Medication Error 1
Break 1

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

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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.