Devices › Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Device brand name · Mesh surgical synthetic urogynecologic
Gynecare Tvt Obturator: medical device reports filed with FDA
868 reports name it, 2012–2026. Manufacturer given most often on reports: Ethicon. Product code OTN.
- 868
- device reports naming the brand
- 0% of all MAUDE reports · about 62 a year
- 15
- reports, 12 months to August 2026
- 30 in the 12 months before
- 6.5%
- classified as malfunction
- 1.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 868 reports that name the brand "Gynecare Tvt Obturator" (mesh surgical synthetic urogynecologic), received between July 2012 and April 2026; the manufacturer given most often on reports is Ethicon. Spellings of one product vary from report to report.
15 reports arrived in the 12 months to August 2026, down 50% from 30 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 (93.5%) and malfunction (6.5%); 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 migration (30%), material integrity problem (2.2%) and break (1.3%). The patient problems coded most often are pain, erosion and not applicable. 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 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 |
|---|---|---|---|
| Migrationthe device moved from where it was placed | 260 | 30% | 4.6% |
| Material integrity problema problem with the device material | 19 | 2.2% | 0.2% |
| Breakthe device broke | 11 | 1.3% | 0.3% |
| Migration or expulsion of device | 8 | 0.9% | 5.2% |
| Hole in material | 4 | 0.5% | 0% |
| Material erosion | 4 | 0.5% | 44.4% |
| Material twisted/bent | 3 | 0.3% | 0.1% |
| Unraveled material | 3 | 0.3% | 0% |
| Device contaminated during manufacture or shipping | 2 | 0.2% | 0% |
| Fracturea broken bone | 2 | 0.2% | 0% |
| Material split, cut or torn | 2 | 0.2% | 0.1% |
| Packaging problem | 2 | 0.2% | 0% |
| Defective component | 1 | 0.1% | 0% |
| Detachment of device or device componentpart of the device came off | 1 | 0.1% | 0.1% |
| Difficult to removethe device was hard to remove | 1 | 0.1% | 0% |
| Insufficient device problem information | 1 | 0.1% | 8.4% |
| Material separation | 1 | 0.1% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.1% | 0.2% |
| Peeled/delaminated | 1 | 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 |
|---|---|---|
| Painpain, site not specified | 394 | 45.4% |
| Erosion | 268 | 30.9% |
| Not applicable | 168 | 19.4% |
| Injurya physical injury | 142 | 16.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 126 | 14.5% |
| Incontinence | 123 | 14.2% |
| Urinary tract infectionbladder or urinary infection | 73 | 8.4% |
| Micturition urgency | 32 | 3.7% |
| Ambulation or postural difficulties | 26 | 3% |
| Hemorrhage/blood loss/bleeding | 26 | 3% |
| Inflammationinflammation | 24 | 2.8% |
| Urinary retentionbeing unable to empty the bladder | 24 | 2.8% |
| Abdominal painstomach or belly pain | 18 | 2.1% |
| Discomfortdiscomfort | 16 | 1.8% |
| Blood loss | 15 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Gynecare Tvt Obturator | Product code OTN | All MAUDE reports |
|---|---|---|---|
| Reports | 868 | 38,649 | 26,136,888 |
| Share of that pool | — | 2.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 10 | 9 |
| Classified as injury | 93.5% | 97.4% | 36.2% |
| Classified as malfunction | 6.5% | 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% |
| Uretex Support Pp Kit X1 | 999 | 0 | 0.1% |
| 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 Gynecare Tvt Obturator reports
How many FDA reports name Gynecare Tvt Obturator?
868 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 15 in the latest 12 months.
What kinds of events are reported?
injury (93.5%) and malfunction (6.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration (30%), material integrity problem (2.2%), break (1.3%), migration or expulsion of device (0.9%) and hole in material (0.5%). 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 Gynecare Tvt Obturator 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.