Device manufacturer, as written on reports

Ethicon: medical device reports filed with FDA

167,721 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.

167,721
reports naming it as manufacturer: 0.6% of all MAUDE reports; 13,600
reports, 12 months to August 2026: 14,858 in the 12 months before; 44%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

167,721 medical device reports received by FDA give Ethicon as the manufacturer of the device involved, 0.6% of the MAUDE database, from January 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

13,600 reports arrived in the 12 months to August 2026, close to the 14,858 of 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 (55.5%), malfunction (44%) and death (0.3%). 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
Tension Free Vaginal Tape	Mesh, surgical, polymeric	8,636	0	0.1%
Gynecare Mesh Unknown	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	5,712	3	0.1%
Gynecare Tvt Retropubic System	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	5,156	0	0%
Gynecare Tvt Obturator System	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	3,830	0	0%
Proceed Surg Mesh/Multi Lyr	Mesh, surgical, polymeric	3,150	29	0%
Gynecare Gynemesh Ps	Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed	2,442	0	0.1%
Gynecare Morcellex Tissue Morcellator	Laparoscope, gynecologic (and accessories)	2,394	0	0%
Physiomesh	Mesh, surgical, polymeric	2,377	0	0.1%
Vicryl Polyglactin 910 Suture Unknown Product	Suture, absorbable, synthetic, polyglycolic acid	2,351	210	1.2%
Prolift Pelvic Floor Repair	Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed	2,273	0	0.1%
Gynecare Tvt Secur System	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling	1,610	0	0%
Prolene Polypropylene Suture Unknown Product	Suture, nonabsorbable, synthetic, polypropylene	1,591	133	2.2%
Gynecare Tvt Oburator System	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	1,488	0	0.1%
PROLENE POLYPROPYLENE Mesh	Mesh, surgical, polymeric	1,353	52	0.1%
PROLENE Polypropylene Suture	Suture, nonabsorbable, synthetic, polypropylene	1,330	177	3.4%
Pvp Medium 6 4cm X 6 4cm	Mesh, surgical, polymeric	1,250	21	0%
Physiomesh Unknown Product	Mesh, surgical, polymeric	1,249	1	0.1%
Gynecare Prolift Total Pelvic Floor Repair System	Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed	1,126	0	0.1%
Coated VICRYL (polyglactin 910) Suture	Suture, absorbable, synthetic, polyglycolic acid	1,104	20	0.5%
Ethicon Physiomesh Composite Mesh 15x20cm Oval	Mesh, surgical, polymeric	1,060	0	0%
Vcl+ Ud 27in 5-0 S/A Tf	Suture, absorbable, synthetic, polyglycolic acid	1,050	158	0.1%
Gynecare X-Tract Morcellator	Laparoscope, gynecologic (and accessories)	1,041	0	0.6%
Prolene Polypropylene Mesh Unknown Product	Mesh, surgical, polymeric	1,038	12	0.5%
Tension Free Vaginal Tape Unknown Product	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	1,031	24	0%
VICRYL Polyglactin 910 Suture	Suture, absorbable, synthetic, polyglycolic acid	1,019	74	0.1%
Coated VICRYL	Suture, absorbable, synthetic, polyglycolic acid	872	851	0%
Vicryl Plus Antibacterial Polyglactin 910 Suture	Suture, absorbable, synthetic, polyglycolic acid	845	0	0.1%
Gynecare Tvt-Aa Abdominal	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	830	0	0%
Lapra-Ty Absorbable X6 Suture Clip	Clip, implantable	740	118	0%
Prolene	Suture, nonabsorbable, synthetic, polypropylene	729	729	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
GAM	Suture, absorbable, synthetic, polyglycolic acid	33,508	20%
FTL	Mesh, surgical, polymeric	29,020	17.3%
OTN	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	24,943	14.9%
NEW	Suture, surgical, absorbable, polydioxanone	14,662	8.7%
GAW	Suture, nonabsorbable, synthetic, polypropylene	14,156	8.4%
OTP	Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed	5,320	3.2%
GAR	Suture, nonabsorbable, synthetic, polyamide	4,050	2.4%
GAN	Suture, absorbable, synthetic	3,769	2.2%
HET	Laparoscope, gynecologic (and accessories)	3,751	2.2%
GAP	Suture, nonabsorbable, silk	3,084	1.8%

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

Death0.3%456

Injury55.5%93,167

Malfunction44%73,760

Other0.1%137

Not given0.1%201

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

Questions about Ethicon reports

How many FDA device reports name Ethicon as manufacturer?

167,721 reports through August 2026, 13,600 of them in the latest 12 months.

Which of its brands appear most often?

Tension Free Vaginal Tape (8,636), Gynecare Mesh Unknown (5,712), Gynecare Tvt Retropubic System (5,156), Gynecare Tvt Obturator System (3,830) and Proceed Surg Mesh/Multi Lyr (3,150).

Which device types does it report on?

suture, absorbable, synthetic, polyglycolic acid (20%), mesh, surgical, polymeric (17.3%), mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator (14.9%) and suture, surgical, absorbable, polydioxanone (8.7%).

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.