Devices › Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Device brand name · Uretex support
Uretex Support Pp Kit X1: medical device reports filed with FDA
999 reports name it, 2006–2017. Manufacturer given most often on reports: Sofradim Production. Product code OTN.
- 999
- device reports naming the brand
- 0% of all MAUDE reports · about 49 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0.7%
- classified as malfunction
- 1.6% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
999 medical device reports received by FDA name the brand "Uretex Support Pp Kit X1" (uretex support); the manufacturer given most often on reports is Sofradim Production; received from January 2006 to February 2017. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 injury (99%), malfunction (0.7%) and death (0.1%); across all mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator reports (product code OTN) death is recorded in 1% and malfunction in 1.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (65.4%), device operates differently than expected (13.6%) and defective device (1.4%). The patient problems coded most often are injury, pain and incontinence. 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 Uretex Support Pp Kit X1 was received in the five years to August 2026; the latest was received in February 2017.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 38,649 reports carrying product code OTN. 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 |
|---|---|---|---|
| Insufficient device problem information | 653 | 65.4% | 8.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 136 | 13.6% | 1.1% |
| Defective devicethe device was defective | 14 | 1.4% | 0.1% |
| Material erosion | 8 | 0.8% | 44.4% |
| Defective component | 6 | 0.6% | 0% |
| Material integrity problema problem with the device material | 4 | 0.4% | 0.2% |
| Extrusion | 2 | 0.2% | 0.8% |
| Material perforation | 2 | 0.2% | 0% |
| Fluid/blood leak | 1 | 0.1% | 0% |
| Mechanical problema mechanical problem | 1 | 0.1% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.1% | 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 |
|---|---|---|
| Injurya physical injury | 762 | 76.3% |
| Painpain, site not specified | 318 | 31.8% |
| Incontinence | 117 | 11.7% |
| Disability | 80 | 8% |
| Urinary tract infectionbladder or urinary infection | 69 | 6.9% |
| Erosion | 60 | 6% |
| Complaint, ill-defined | 54 | 5.4% |
| Prolapse | 48 | 4.8% |
| Blood loss | 43 | 4.3% |
| Urinary retentionbeing unable to empty the bladder | 37 | 3.7% |
| Urinary frequency / polyuria | 36 | 3.6% |
| Micturition urgency | 32 | 3.2% |
| Dysuriapain on passing urine | 28 | 2.8% |
| Abdominal painstomach or belly pain | 26 | 2.6% |
| Discomfortdiscomfort | 25 | 2.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Uretex Support Pp Kit X1 | Product code OTN | All MAUDE reports |
|---|---|---|---|
| Reports | 999 | 38,649 | 26,136,888 |
| Share of that pool | — | 2.6% | 0% |
| Classified as death, per 1,000 reports | 1 | 10 | 9 |
| Classified as injury | 99% | 97.4% | 36.2% |
| Classified as malfunction | 0.7% | 1.6% | 62.3% |
| Filed by the manufacturer | 99.9% | 97.8% | 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 OTN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Gynecare Tvt Retropubic System | 5,752 | 0 | 0% |
| Gynecare Tvt Obturator System | 4,330 | 0 | 0% |
| Tension Free Vaginal Tape | 9,355 | 0 | 0.1% |
| Gynecare Mesh Unknown | 5,830 | 3 | 0.1% |
| Gynecare Tvt Oburator System | 1,578 | 0 | 0.1% |
| Tension Free Vaginal Tape Unknown Product | 1,161 | 24 | 0% |
| Gynecare Tvt-Aa Abdominal | 905 | 0 | 0% |
| Advantage Fit System | 1,496 | 10 | 0.1% |
| Gynecare Tvt Obturator | 868 | 15 | 0% |
| Gynecare Tvt Exact Continence System | 682 | 0 | 0% |
| Tension Free Vaginal Tape - Obturator Unknown Prod | 676 | 5 | 0% |
| Advantage? System | 3,537 | 13 | 0% |
| Obtryx System | 6,031 | 1 | 0% |
| Gynecare TVT | 679 | 3 | 0% |
| Obtape Transobturator Sling | 1,304 | 0 | 0% |
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 Uretex Support Pp Kit X1 reports
How many FDA reports name Uretex Support Pp Kit X1?
999 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?
injury (99%), malfunction (0.7%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (65.4%), device operates differently than expected (13.6%), defective device (1.4%), material erosion (0.8%) and defective component (0.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and distributor reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Uretex Support Pp Kit X1 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.