Devices › Suture, nonabsorbable, synthetic, polypropylene
Device brand name · Suture non-absorbable
PROLENE Polypropylene Suture: medical device reports filed with FDA
2,047 reports name it, 1996–2026. Manufacturer given most often on reports: Ethicon. Product code GAW.
- 2,047
- device reports naming the brand
- 0% of all MAUDE reports · about 68 a year
- 177
- reports, 12 months to August 2026
- 0 in the 12 months before
- 51.5%
- classified as malfunction
- 80.5% across the product code
- 3.4%
- classified as death, as reported
- 69 reports · not verified by FDA
2,047 medical device reports received by FDA name the brand "PROLENE Polypropylene Suture" (suture non-absorbable); the manufacturer given most often on reports is Ethicon; received from August 1996 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
177 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 malfunction (51.5%), injury (44.8%) and death (3.4%); across all suture, nonabsorbable, synthetic, polypropylene reports (product code GAW) death is recorded in 1.1% and malfunction in 80.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (34%), material frayed (15.8%) and other (for use when an appropriate device code cannot be identified) (7.7%). The patient problems coded most often are surgical procedure, wound dehiscence and failure to anastomose. 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 20,028 reports carrying product code GAW. 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 | 696 | 34% | 45.5% |
| Material frayed | 324 | 15.8% | 4.7% |
| Other (for use when an appropriate device code cannot be identified) | 157 | 7.7% | 0.9% |
| Needle, separation | 141 | 6.9% | 1.1% |
| Replace | 130 | 6.4% | 1% |
| Split | 70 | 3.4% | 0.5% |
| Explanted | 62 | 3% | 0.4% |
| Suture line separation | 49 | 2.4% | 0.5% |
| Material separation | 31 | 1.5% | 22.8% |
| Reactiona reaction, type not specified | 28 | 1.4% | 0.2% |
| Suture line disruption | 27 | 1.3% | 1.9% |
| Bent | 21 | 1% | 0.2% |
| Detachment of device component | 18 | 0.9% | 0.9% |
| Kinkedthe tube or line kinked | 18 | 0.9% | 0.1% |
| Unsealed device packaging | 18 | 0.9% | 0.1% |
| Out-of-box failure | 16 | 0.8% | 0.1% |
| Unraveled material | 16 | 0.8% | 0.3% |
| Device remains implanted | 13 | 0.6% | 0.1% |
| Device markings/labelling problema problem with the device markings or label | 11 | 0.5% | 0.5% |
| Insufficient device problem information | 11 | 0.5% | 0.8% |
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 | 345 | 16.9% |
| Wound dehiscencea wound reopened | 154 | 7.5% |
| Failure to anastomose | 82 | 4% |
| Surgical procedure, additional | 75 | 3.7% |
| Deaththe patient died; cause not stated by this term | 70 | 3.4% |
| Bleeding | 63 | 3.1% |
| Hemorrhage/blood loss/bleeding | 61 | 3% |
| Other (for use when an appropriate patient code cannot be identified) | 56 | 2.7% |
| Nonresorbable materials, unretrieved in body | 51 | 2.5% |
| Painpain, site not specified | 47 | 2.3% |
| Surgical procedure, repeated | 47 | 2.3% |
| Blood loss | 43 | 2.1% |
| Not applicable | 43 | 2.1% |
| Organ dehiscence | 33 | 1.6% |
| Hematomaa collection of blood under the skin or in tissue | 32 | 1.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | PROLENE Polypropylene Suture | Product code GAW | All MAUDE reports |
|---|---|---|---|
| Reports | 2,047 | 20,028 | 26,136,888 |
| Share of that pool | — | 10.2% | 0% |
| Classified as death, per 1,000 reports | 34 | 11 | 9 |
| Classified as injury | 44.8% | 17.9% | 36.2% |
| Classified as malfunction | 51.5% | 80.5% | 62.3% |
| Filed by the manufacturer | 99.6% | 98.4% | 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 GAW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Prolene Polypropylene Suture Unknown Product | 1,623 | 133 | 2.2% |
| Prolene | 779 | 729 | 0.3% |
| Surgipro ll | 570 | 37 | 0.5% |
| Prlne Blu 36in 5-0 D/A Rb-1 | 310 | 97 | 0.3% |
| Surgipro | 1,189 | 89 | 0.9% |
| Gore-Tex Suture | 241 | 16 | 1.2% |
| Prolene Sut 30in 75cm 6-0 Blu | 204 | 43 | 0.5% |
| Prolene Suture 30 75cm 6-0 Blu | 199 | 0 | 0% |
| Prlne Blu 30in 6-0 D/A C-1 | 184 | 29 | 0% |
| Prolene Blue 0 7m 60cm W/Ndl | 170 | 0 | 0% |
| Non Absorbable Surgical Suture | 337 | 39 | 0% |
| Prlne Blu 24in 7-0 D/A Bv-1 | 157 | 37 | 1.9% |
| Prolene Suture 36 90cm 5-0 Blu | 156 | 0 | 0% |
| Prlne Blu 24in 7-0 D/A Bv175-6 Mp | 151 | 28 | 0% |
| Unknown Suture Product | 448 | 28 | 0.9% |
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 PROLENE Polypropylene Suture reports
How many FDA reports name PROLENE Polypropylene Suture?
2,047 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 177 in the latest 12 months.
What kinds of events are reported?
malfunction (51.5%), injury (44.8%) and death (3.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (34%), material frayed (15.8%), other (for use when an appropriate device code cannot be identified) (7.7%), needle, separation (6.9%) and replace (6.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that PROLENE Polypropylene 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.