Devices › Suture, nonabsorbable, synthetic, polyamide
Device brand name · Suture nonabsorbable synthetic
ETHILON Nylon Suture: medical device reports filed with FDA
403 reports name it, 1997–2026. Manufacturer given most often on reports: Ethicon. Product code GAR.
- 403
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 9
- reports, 12 months to August 2026
- 0 in the 12 months before
- 47.6%
- classified as malfunction
- 84.9% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
403 medical device reports received by FDA name the brand "ETHILON Nylon Suture" (suture nonabsorbable synthetic); the manufacturer given most often on reports is Ethicon; received from August 1997 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
9 reports arrived in the 12 months to August 2026, with none 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 (51.9%), malfunction (47.6%) and death (0.2%); across all suture, nonabsorbable, synthetic, polyamide reports (product code GAR) death is recorded in 0% and malfunction in 84.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (32%), other (for use when an appropriate device code cannot be identified) (14.4%) and reaction (8.9%). The patient problems coded most often are surgical procedure, treatment with medication(s) and wound dehiscence. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 6,142 reports carrying product code GAR. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 129 | 32% | 45.5% |
| Other (for use when an appropriate device code cannot be identified) | 58 | 14.4% | 1.1% |
| Reactiona reaction, type not specified | 36 | 8.9% | 0.7% |
| Needle, separation | 16 | 4% | 0.3% |
| Detachment of device component | 14 | 3.5% | 1.4% |
| Bent | 12 | 3% | 0.3% |
| Unsealed device packaging | 8 | 2% | 0.2% |
| Device markings/labelling problema problem with the device markings or label | 4 | 1% | 1.1% |
| Tear, rip or hole in device packaging | 4 | 1% | 0.2% |
| Component incompatible | 3 | 0.7% | 0.2% |
| Insufficient device problem information | 2 | 0.5% | 0.4% |
| Material separation | 2 | 0.5% | 21.3% |
| Detachment of device or device componentpart of the device came off | 1 | 0.2% | 5.7% |
| Device fell | 1 | 0.2% | 0% |
| Implant extrusion | 1 | 0.2% | 0% |
| Incorrect device or component shipped | 1 | 0.2% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.2% | 0.3% |
| Seal, defective | 1 | 0.2% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Surgical procedure | 55 | 13.6% |
| Treatment with medication(s) | 37 | 9.2% |
| Wound dehiscencea wound reopened | 30 | 7.4% |
| Reactiona reaction, type not specified | 27 | 6.7% |
| Therapy/non-surgical treatment, additional | 23 | 5.7% |
| Inflammationinflammation | 18 | 4.5% |
| Erythemaskin redness | 15 | 3.7% |
| Nonresorbable materials, unretrieved in body | 13 | 3.2% |
| Drainage | 12 | 3% |
| Low blood pressure/ hypotension | 12 | 3% |
| Tachycardiafast heart rate | 12 | 3% |
| Transfusion of blood products | 12 | 3% |
| Swellingswelling | 10 | 2.5% |
| Surgical procedure, additional | 9 | 2.2% |
| Other (for use when an appropriate patient code cannot be identified) | 7 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | ETHILON Nylon Suture | Product code GAR | All MAUDE reports |
|---|---|---|---|
| Reports | 403 | 6,142 | 26,136,888 |
| Share of that pool | — | 6.6% | 0% |
| Classified as death, per 1,000 reports | 2 | 0 | 9 |
| Classified as injury | 51.9% | 14.7% | 36.2% |
| Classified as malfunction | 47.6% | 84.9% | 62.3% |
| Filed by the manufacturer | 99.5% | 98.8% | 94.9% |
Shares are of reports, not 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."
Other brands with product code GAR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Monosof | 410 | 89 | 0% |
| Alcon Closure System (ACS), Nylon | 323 | 152 | 0% |
| Ethilon Nylon Suture Unknown Product | 191 | 6 | 0.5% |
| Ethilon | 186 | 183 | 0% |
| Non Absorbable Surgical Suture | 337 | 39 | 0% |
| McKesson | 446 | 74 | 0% |
| Unknown Suture Product | 448 | 28 | 0.9% |
| ETHIBOND Extra & Excel Polyester Suture | 317 | 34 | 0% |
| Surgicel Absorbable Hemostat | 289 | 0 | 2.1% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about ETHILON Nylon Suture reports
How many FDA reports name ETHILON Nylon Suture?
403 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.
What kinds of events are reported?
injury (51.9%), malfunction (47.6%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (32%), other (for use when an appropriate device code cannot be identified) (14.4%), reaction (8.9%), needle, separation (4%) and detachment of device component (3.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that ETHILON Nylon Suture was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.