Device manufacturer, as written on reports

C R Bard: medical device reports filed with FDA

5,145 reports name it as the manufacturer of the device involved, 1992–2026.

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.

5,145
reports naming it as manufacturer: 0% of all MAUDE reports; 166
reports, 12 months to August 2026: 271 in the 12 months before; 40.4%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

5,145 medical device reports received by FDA give C R Bard as the manufacturer of the device involved, 0% of the MAUDE database, from April 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

166 reports arrived in the 12 months to August 2026, down 39% from 271 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 (54.6%), malfunction (40.4%) and other (2.5%). 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
Unknown Women's Health Product	Mesh, surgical, polymeric	373	0	0%
Bard Tegress Urethral Bulking Agent	Agent, bulking, injectable for gastro-urology use	220	0	0%
Bard	Port & catheter, implanted, subcutaneous, intravascular	196	2	1.8%
Unknown Women's Health Mesh Product	Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed	151	0	0%
Avaulta Plus Biosynthetic Support System	Mesh, surgical, polymeric	115	0	0%
Align Urethral Support System	Mesh, surgical, polymeric	67	0	0%
Pelvisoft Acellular Collagen Biomesh	Mesh, surgical	58	0	0%
Align To Urethral Support System	Mesh, surgical, polymeric	48	0	0%
SureStep Foley Tray System Bardex IC Complete Care	Catheter, urological (antimicrobial) and accessories	40	7	0%
Foley Catheter	Catheter, urological	39	2	0.8%
Bardex Lubri-Sil All-Silicone Temp Sensing Foley Catheter	Catheter, retention type, balloon	33	62	0%
Bard DigniShield Stool Management System	Tubes, gastrointestinal (and accessories)	30	94	0.7%
Surestep	Glucose oxidase, glucose	30	0	0.1%
Bardex Lubri-Sil All-Silicone Foley Catheter	Catheter, retention type, balloon	25	294	0.1%
Pelvilace Biourethral Support System	Mesh, surgical, polymeric	22	0	0.3%
Avaulta Plus Biosynthetic Support System - Anterior	Mesh, surgical, polymeric	19	0	0%
Avaulta Plus Biosynthetic Support System - Posterior	Mesh, surgical, polymeric	17	0	0%
Pelvilace To Biourethral Support System	Mesh, surgical, polymeric	17	0	0%
Bardex All-Silicone Foley Catheter	Catheter, retention type, balloon	15	196	0%
Ajust Adjustable Single Incision Sling	Mesh, surgical, polymeric	14	0	0%
Channel Drain	Catheter, irrigation	14	66	0%
PureWick Female External Catheter	Collector, urine, powered, non indwelling catheter	12	114	0.6%
Bardex Lubricath Foley Catheter	Catheter, coude	11	653	0%
Closed Wound Suction	Apparatus, suction, single patient use, portable, nonpowered	10	80	0%
Bardex Lubri-Sil I.C. All-Silicone Foley Catheter	Catheter, urological (antimicrobial) and accessories	8	620	0%
Pelvicol Acellular Collagen Matrix	Mesh, surgical, polymeric	7	0	0%
Align R Urethral Support System	Mesh, surgical, polymeric	6	0	0%
Align S Urethral Support System	Mesh, surgical, polymeric	4	0	0%
Bard Touchless Plus Unisex Pre-Lubricated Vinyl Urethral Catheter Kit	Tray, catheterization, sterile urethral, with or without catheter (kit)	4	22	0%
Bardex I.C. Foley Catheter	Catheter, urological (antimicrobial) and accessories	4	562	0%

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	1,279	24.9%
KOD	Catheter, urological	576	11.2%
EZL	Catheter, retention type, balloon	489	9.5%
GCY	Apparatus, suction, single patient use, portable, nonpowered	266	5.2%
MJC	Catheter, urological (antimicrobial) and accessories	262	5.1%
LNM	Agent, bulking, injectable for gastro-urology use	233	4.5%
EZC	Catheter, coude	166	3.2%
LJT	Port & catheter, implanted, subcutaneous, intravascular	159	3.1%
OTP	Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed	129	2.5%
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days	122	2.4%

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%35

Injury54.6%2,809

Malfunction40.4%2,080

Other2.5%130

Not given1.8%91

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

Questions about C R Bard reports

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

5,145 reports through August 2026, 166 of them in the latest 12 months.

Which of its brands appear most often?

Unknown Women's Health Product (373), Bard Tegress Urethral Bulking Agent (220), Bard (196), Unknown Women's Health Mesh Product (151) and Avaulta Plus Biosynthetic Support System (115).

Which device types does it report on?

mesh, surgical, polymeric (24.9%), catheter, urological (11.2%), catheter, retention type, balloon (9.5%) and apparatus, suction, single patient use, portable, nonpowered (5.2%).

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.