Device manufacturer, as written on reports

Davol Sub C R Bard: medical device reports filed with FDA

57,177 reports name it as the manufacturer of the device involved, 1997–2025.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

57,177
reports naming it as manufacturer: 0.2% of all MAUDE reports; 1
reports, 12 months to August 2026: 454 in the 12 months before; 2.3%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

57,177 medical device reports received by FDA give Davol Sub C R Bard as the manufacturer of the device involved, 0.2% of the MAUDE database, from May 1997 to October 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1 reports arrived in the 12 months to August 2026, down 100% from 454 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (96.6%), malfunction (2.3%) and death (0.7%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Bard Flat Mesh	Mesh, surgical, polymeric	7,151	110	0.5%
PerFix Plug	Mesh, surgical, polymeric	6,757	167	0.3%
Ventralight ST Mesh	Mesh, surgical, polymeric	5,105	106	0.5%
Ventralex ST	Mesh, surgical, polymeric	4,381	101	0.4%
Mesh Ventralex	Mesh, surgical, polymeric	4,062	5	0.4%
3DMax	Mesh, surgical, polymeric	3,177	155	0.1%
Ventrio ST	Mesh, surgical, polymeric	2,363	51	0.7%
Mesh - Composix Kugel	Mesh, surgical, polymeric	2,113	42	3.5%
Mesh Composix Kugel	Mesh, surgical, polymeric	1,878	1	1.5%
Ventralex	Mesh, surgical, polymeric	1,754	0	0.4%
SepraMesh IP	Mesh, surgical, polymeric	1,556	43	0.8%
Kugel Patch	Mesh, surgical, polymeric	1,507	29	0.4%
Ventrio Mesh	Mesh, surgical, polymeric	1,435	30	0.5%
Composix Mesh E/X	Mesh, surgical, polymeric	1,368	0	1.5%
Mesh - Ventralex	Mesh, surgical, polymeric	1,270	98	0.6%
Composix Kugel	Mesh, surgical, polymeric	1,000	0	0.7%
Ventralight ST	Mesh, surgical, polymeric	860	0	0.3%
Mesh Composix	Mesh, surgical, polymeric	673	0	0.8%
Mesh Composix L/P	Mesh, surgical, polymeric	660	0	0.4%
3DMax Light	Mesh, surgical, polymeric	597	84	0%
Salute Fixation Device	Staple, implantable	521	0	0%
Ventrio	Mesh, surgical, polymeric	471	0	0.2%
Phasix Mesh	Surgical film	465	57	0.7%
Composix E/X	Mesh, surgical, polymeric	452	0	1.5%
Bard Soft Mesh	Mesh, surgical, polymeric	444	53	0.6%
Mesh-Composix Kugel	Mesh, surgical, polymeric	334	0	2.4%
Mesh - Composix	Mesh, surgical, polymeric	331	14	1.7%
Ventralight ST w/ Echo	Mesh, surgical, polymeric	268	52	0.1%
Phasix ST Mesh	Mesh, surgical, absorbable, abdominal hernia	262	70	1.5%
PerFix Plug Light	Mesh, surgical, polymeric	223	15	0.3%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
FTL	Mesh, surgical, polymeric	54,892	96%
GDW	Staple, implantable	763	1.3%
OOD	Surgical film	486	0.8%
OWT	Mesh, surgical, absorbable, abdominal hernia	312	0.5%
FTM	Mesh, surgical	255	0.4%
GCJ	Laparoscope, general & plastic surgery	124	0.2%
FQH	Lavage, jet	89	0.2%
LMG	Agent, absorbable hemostatic, non-collagen based	44	0.1%
NBE	Sealant, polymerizing	29	0.1%
CAC	Apparatus, autotransfusion	28	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.7%391

Injury96.6%55,235

Malfunction2.3%1,339

Other0.3%184

Not given0%28

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Davol Sub C R Bard reports

How many FDA device reports name Davol Sub C R Bard as manufacturer?

57,177 reports through August 2026, 1 of them in the latest 12 months.

Which of its brands appear most often?

Bard Flat Mesh (7,151), PerFix Plug (6,757), Ventralight ST Mesh (5,105), Ventralex ST (4,381) and Mesh Ventralex (4,062).

Which device types does it report on?

mesh, surgical, polymeric (96%), staple, implantable (1.3%), surgical film (0.8%) and mesh, surgical, absorbable, abdominal hernia (0.5%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.