Devices › Suture, nonabsorbable, synthetic, polypropylene
Device brand name · Suture nonabsorbable synthetic polypropylene
Prolene Polypropylene Suture Unknown Product: medical device reports filed with FDA
1,623 reports name it, 2017–2026. Manufacturer given most often on reports: Ethicon. Product code GAW.
- 1,623
- device reports naming the brand
- 0% of all MAUDE reports · about 189 a year
- 133
- reports, 12 months to August 2026
- 201 in the 12 months before
- 5.7%
- classified as malfunction
- 80.5% across the product code
- 2.2%
- classified as death, as reported
- 36 reports · not verified by FDA
FDA's MAUDE database holds 1,623 reports that name the brand "Prolene Polypropylene Suture Unknown Product" (suture nonabsorbable synthetic polypropylene), received between December 2017 and March 2026; the manufacturer given most often on reports is Ethicon. Spellings of one product vary from report to report.
133 reports arrived in the 12 months to August 2026, down 34% from 201 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 (92.1%), malfunction (5.7%) and death (2.2%); 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 (5.7%), insufficient device problem information (2.6%) and material separation (2.6%). The patient problems coded most often are not applicable, hemorrhage/blood loss/bleeding and pain. 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 | 93 | 5.7% | 45.5% |
| Insufficient device problem information | 43 | 2.6% | 0.8% |
| Material separation | 43 | 2.6% | 22.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 22 | 1.4% | 0.5% |
| Patient-device incompatibilitythe device did not suit the patient | 20 | 1.2% | 0.2% |
| Positioning failure | 12 | 0.7% | 0.1% |
| Migrationthe device moved from where it was placed | 6 | 0.4% | 0% |
| Material frayed | 5 | 0.3% | 4.7% |
| Improper or incorrect procedure or method | 4 | 0.2% | 0.1% |
| Malposition of device | 4 | 0.2% | 0% |
| Material twisted/bent | 4 | 0.2% | 0.6% |
| Defective component | 3 | 0.2% | 0.2% |
| Extrusion | 3 | 0.2% | 0% |
| Leak/splashthe device leaked | 3 | 0.2% | 0.1% |
| Material protrusion/extrusion | 3 | 0.2% | 0% |
| Migration or expulsion of device | 3 | 0.2% | 0% |
| Contamination | 2 | 0.1% | 0.1% |
| Degraded | 2 | 0.1% | 0% |
| Device slipped | 2 | 0.1% | 0.1% |
| Material erosion | 2 | 0.1% | 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 |
|---|---|---|
| Not applicable | 333 | 20.5% |
| Hemorrhage/blood loss/bleeding | 204 | 12.6% |
| Painpain, site not specified | 192 | 11.8% |
| Hernia | 151 | 9.3% |
| Hematomaa collection of blood under the skin or in tissue | 147 | 9.1% |
| Post operative wound infection | 143 | 8.8% |
| Seromaa collection of fluid under the skin | 143 | 8.8% |
| Fistula | 138 | 8.5% |
| Wound dehiscencea wound reopened | 116 | 7.1% |
| Blood loss | 85 | 5.2% |
| Failure to anastomose | 83 | 5.1% |
| Obstruction/occlusion | 80 | 4.9% |
| Abscessa collection of pus | 62 | 3.8% |
| Swelling/ edema | 59 | 3.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 57 | 3.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Prolene Polypropylene Suture Unknown Product | Product code GAW | All MAUDE reports |
|---|---|---|---|
| Reports | 1,623 | 20,028 | 26,136,888 |
| Share of that pool | — | 8.1% | 0% |
| Classified as death, per 1,000 reports | 22 | 11 | 9 |
| Classified as injury | 92.1% | 17.9% | 36.2% |
| Classified as malfunction | 5.7% | 80.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 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 | 2,047 | 177 | 3.4% |
| 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 Unknown Product reports
How many FDA reports name Prolene Polypropylene Suture Unknown Product?
1,623 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 133 in the latest 12 months.
What kinds of events are reported?
injury (92.1%), malfunction (5.7%) and death (2.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (5.7%), insufficient device problem information (2.6%), material separation (2.6%), device operates differently than expected (1.4%) and patient-device incompatibility (1.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). 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 Unknown Product 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.