Devices › Suture, absorbable, synthetic
Device brand name · Suture absorbable
Monocryl Plus Antibacterial Sutures: medical device reports filed with FDA
194 reports name it, 2008–2013. Manufacturer given most often on reports: Ethicon. Product code GAN.
- 194
- device reports naming the brand
- 0% of all MAUDE reports · about 11 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 80.9%
- classified as malfunction
- 64.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 194 reports that name the brand "Monocryl Plus Antibacterial Sutures" (suture absorbable), received between March 2008 and June 2013; the manufacturer given most often on reports is Ethicon. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and 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 malfunction (80.9%) and injury (19.1%); across all suture, absorbable, synthetic reports (product code GAN) death is recorded in 0.1% and malfunction in 64.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are needle, separation (42.3%), break (33.5%) and other (for use when an appropriate device code cannot be identified) (9.3%). The patient problems coded most often are wound dehiscence, inflammation and reaction. 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
No report naming Monocryl Plus Antibacterial Sutures was received in the five years to August 2026; the latest was received in June 2013.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,612 reports carrying product code GAN. 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 |
|---|---|---|---|
| Needle, separation | 82 | 42.3% | 1.7% |
| Breakthe device broke | 65 | 33.5% | 33.3% |
| Other (for use when an appropriate device code cannot be identified) | 18 | 9.3% | 5.2% |
| Reactiona reaction, type not specified | 11 | 5.7% | 3.9% |
| Unsealed device packaging | 1 | 0.5% | 0.2% |
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 |
|---|---|---|
| Wound dehiscencea wound reopened | 11 | 5.7% |
| Inflammationinflammation | 7 | 3.6% |
| Reactiona reaction, type not specified | 6 | 3.1% |
| Treatment with medication(s) | 6 | 3.1% |
| Nonresorbable materials, unretrieved in body | 4 | 2.1% |
| Surgical procedure | 4 | 2.1% |
| Extrusion | 3 | 1.5% |
| Painpain, site not specified | 3 | 1.5% |
| Rashskin rash | 3 | 1.5% |
| Scar tissue | 3 | 1.5% |
| Granuloma | 2 | 1% |
| Allergic reactionan allergic reaction | 1 | 0.5% |
| Other (for use when an appropriate patient code cannot be identified) | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Monocryl Plus Antibacterial Sutures | Product code GAN | All MAUDE reports |
|---|---|---|---|
| Reports | 194 | 5,612 | 26,136,888 |
| Share of that pool | — | 3.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 19.1% | 35.4% | 36.2% |
| Classified as malfunction | 80.9% | 64.3% | 62.3% |
| Filed by the manufacturer | 100% | 97.2% | 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 GAN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| MONOCRYL Poliglecaprone 25 Suture Unknown Product | 608 | 48 | 0.2% |
| MONOCRYL (poliglecaprone 25) Suture | 638 | 24 | 0% |
| Monocryl | 181 | 151 | 0% |
| Panacryl L-Lactide/Glycolide Suture | 360 | 0 | 0% |
| Coated VICRYL (polyglactin 910) Suture | 1,930 | 20 | 0.5% |
| Unknown Suture Product | 448 | 28 | 0.9% |
| Surgipro | 1,189 | 89 | 0.9% |
| ETHILON Nylon Suture | 403 | 9 | 0.2% |
| Gut Surgical Suture | 311 | 0 | 0.3% |
| Unknown Polysorb Suture | 173 | 10 | 0.6% |
| Auto Suture Endo Clip L | 233 | 0 | 0% |
| Auto Suture Versaport 5mm-11mm | 317 | 0 | 0.3% |
| Coated Vicryl Plus Antibacterial Polyglactin 910 | 724 | 0 | 0% |
| Ethicon | 1,100 | 164 | 2.3% |
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 Monocryl Plus Antibacterial Sutures reports
How many FDA reports name Monocryl Plus Antibacterial Sutures?
194 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (80.9%) and injury (19.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
needle, separation (42.3%), break (33.5%), other (for use when an appropriate device code cannot be identified) (9.3%), reaction (5.7%) and unsealed device packaging (0.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Monocryl Plus Antibacterial Sutures 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.