Devices › Mesh, surgical, polymeric
Device brand name · Mesh surgical polymeric
Mesh Sofradim - Parietex Composite Mesh: medical device reports filed with FDA
2,946 reports name it, 2017–2026. Manufacturer given most often on reports: Sofradim Production Sas. Product code FTL.
- 2,946
- device reports naming the brand
- 0% of all MAUDE reports · about 321 a year
- 16
- reports, 12 months to August 2026
- 35 in the 12 months before
- 0.2%
- classified as malfunction
- 2.5% across the product code
- 1.5%
- classified as death, as reported
- 44 reports · not verified by FDA
FDA's MAUDE database holds 2,946 reports that name the brand "Mesh Sofradim - Parietex Composite Mesh" (mesh surgical polymeric), received between May 2017 and July 2026; the manufacturer given most often on reports is Sofradim Production Sas. Spellings of one product vary from report to report.
16 reports arrived in the 12 months to August 2026, down 54% from 35 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 (98.3%), death (1.5%) and malfunction (0.2%); across all mesh, surgical, polymeric reports (product code FTL) death is recorded in 0.5% and malfunction in 2.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration or expulsion of device (32.4%), patient device interaction problem (32.1%) and mechanics altered (19.5%). The patient problems coded most often are hernia, pain and adhesion(s). 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 170,304 reports carrying product code FTL. 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 |
|---|---|---|---|
| Migration or expulsion of device | 955 | 32.4% | 4% |
| Patient device interaction problem | 945 | 32.1% | 18.9% |
| Mechanics altered | 573 | 19.5% | 3.2% |
| Material deformation | 178 | 6% | 2.3% |
| Loss of or failure to bond | 161 | 5.5% | 0.3% |
| Material split, cut or torn | 143 | 4.9% | 0.7% |
| Material integrity problema problem with the device material | 138 | 4.7% | 0.6% |
| Insufficient device problem information | 113 | 3.8% | 26.3% |
| Material erosion | 104 | 3.5% | 5.4% |
| Degraded | 94 | 3.2% | 0.3% |
| Material perforation | 49 | 1.7% | 0.2% |
| Patient-device incompatibilitythe device did not suit the patient | 29 | 1% | 7.2% |
| Detachment of device or device componentpart of the device came off | 19 | 0.6% | 0.3% |
| Defective devicethe device was defective | 15 | 0.5% | 34.3% |
| Product quality problem | 11 | 0.4% | 0.1% |
| Entrapment of device | 6 | 0.2% | 0.3% |
| Defective component | 3 | 0.1% | 0.1% |
| Failure to adhere or bond | 2 | 0.1% | 0% |
| Human-device interface problem | 1 | 0% | 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 |
|---|---|---|
| Hernia | 2,588 | 87.8% |
| Painpain, site not specified | 2,564 | 87% |
| Adhesion(s) | 2,496 | 84.7% |
| Injurya physical injury | 2,244 | 76.2% |
| Inflammationinflammation | 1,187 | 40.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 981 | 33.3% |
| Obstruction/occlusion | 973 | 33% |
| Abdominal painstomach or belly pain | 855 | 29% |
| Abscessa collection of pus | 826 | 28% |
| Scar tissue | 705 | 23.9% |
| Seromaa collection of fluid under the skin | 651 | 22.1% |
| Impaired healingslow healing | 615 | 20.9% |
| Discomfortdiscomfort | 612 | 20.8% |
| Fistula | 592 | 20.1% |
| Fluid discharge | 567 | 19.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Mesh Sofradim - Parietex Composite Mesh | Product code FTL | All MAUDE reports |
|---|---|---|---|
| Reports | 2,946 | 170,304 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 15 | 5 | 9 |
| Classified as injury | 98.3% | 96.5% | 36.2% |
| Classified as malfunction | 0.2% | 2.5% | 62.3% |
| Filed by the manufacturer | 100% | 97.4% | 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 FTL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Bard Flat Mesh | 8,299 | 110 | 0.5% |
| PerFix Plug | 8,256 | 167 | 0.3% |
| Parietex | 6,304 | 320 | 1% |
| Ventralight ST Mesh | 5,813 | 106 | 0.5% |
| Obtryx System | 6,031 | 1 | 0% |
| Ventralex ST | 5,365 | 101 | 0.4% |
| Tension Free Vaginal Tape | 9,355 | 0 | 0.1% |
| Mesh Ventralex | 4,661 | 5 | 0.4% |
| 3DMax | 3,971 | 155 | 0.1% |
| ProGrip | 3,820 | 412 | 0.8% |
| Proceed Surg Mesh/Multi Lyr | 3,199 | 29 | 0% |
| Advantage? System | 3,537 | 13 | 0% |
| Ventrio ST | 2,751 | 51 | 0.7% |
| Symbotex | 2,741 | 190 | 1.2% |
| Mesh - Composix Kugel | 2,682 | 42 | 3.5% |
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 Mesh Sofradim - Parietex Composite Mesh reports
How many FDA reports name Mesh Sofradim - Parietex Composite Mesh?
2,946 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 16 in the latest 12 months.
What kinds of events are reported?
injury (98.3%), death (1.5%) and malfunction (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration or expulsion of device (32.4%), patient device interaction problem (32.1%), mechanics altered (19.5%), material deformation (6%) and loss of or failure to bond (5.5%). 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 Mesh Sofradim - Parietex Composite Mesh 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.