2026 data Public-data reference. official source

Mesh, Surgical, Absorbable, Abdominal Hernia

Open-data reference.

FDA MAUDE adverse event data · 2014–2026

What the Data Shows About Mesh, Surgical, Absorbable, Abdominal Hernia

The FDA MAUDE database aggregates 547 adverse-event reports for Mesh, Surgical, Absorbable, Abdominal Hernia spanning the period from 2014 through 2026. Of these, 7 are classified as death reports, 485 as injury reports, and 54 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 4 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 Defective Device topping the list at 261 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 13 years of MAUDE data, with the peak single-year volume reaching 104 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.

547
Total Reports
7
Death Reports
485
Injury Reports
54
Malfunctions

Event Types

Injury 485 (88.7%)
Malfunction 54 (9.9%)
Death 7 (1.3%)
1 (0.2%)

Patient Outcomes

Required Intervention 277 (44.7%)
Disability 134 (21.6%)
Other 67 (10.8%)
R 60 (9.7%)
Hospitalization 53 (8.5%)
8 (1.3%)
S 5 (0.8%)
Death 5 (0.8%)
H 3 (0.5%)
O 3 (0.5%)
Life Threatening 3 (0.5%)
D 2 (0.3%)

Top Product Problems

Defective Device 261
Patient Device Interaction Problem 245
Insufficient Information 123
Patient-Device Incompatibility 91
Adverse Event Without Identified Device or Use Problem 29
Tear, Rip or Hole in Device Packaging 26
Incorrect, Inadequate or Imprecise Result or Readings 6
Expiration Date Error 5
Material Separation 5
Device Appears to Trigger Rejection 3
Device Contamination with Chemical or Other Material 3
Detachment of Device or Device Component 2
Device Operates Differently Than Expected 2
Improper or Incorrect Procedure or Method 2
Material Deformation 2
Migration 2
Torn Material 2
Use of Device Problem 2
Appropriate Term/Code Not Available 1
Biocompatibility 1

Yearly Trend

14
2014: 1
15
2015: 1
16
2016: 3
17
2017: 7
18
2018: 31
19
2019: 61
20
2020: 45
21
2021: 58
22
2022: 104
23
2023: 76
24
2024: 65
25
2025: 84
26
2026: 11

Related Entities for Mesh, Surgical, Absorbable, Abdominal Hernia

Compare DAVOL INC., SUB. C.R. BARD, INC. vs DAVOL INC., SUB. C.R. BARD, INC. -1213643 →

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.