Devices › Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Device brand name · Mesh surgical synthetic urogynecologic
Gynecare Tvt Obturator W Lasr: medical device reports filed with FDA
430 reports name it, 2013–2026. Manufacturer given most often on reports: Ethicon. Product code OTN.
- 430
- device reports naming the brand
- 0% of all MAUDE reports · about 33 a year
- 14
- reports, 12 months to August 2026
- 34 in the 12 months before
- 5.3%
- classified as malfunction
- 1.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
430 medical device reports received by FDA name the brand "Gynecare Tvt Obturator W Lasr" (mesh surgical synthetic urogynecologic); the manufacturer given most often on reports is Ethicon; received from June 2013 to April 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
14 reports arrived in the 12 months to August 2026, down 59% from 34 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 (94.7%) and malfunction (5.3%); 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 (29.1%), material integrity problem (1.9%) and migration or expulsion of device (1.2%). The patient problems coded most often are pain, erosion and urinary tract infection. 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 | 125 | 29.1% | 4.6% |
| Material integrity problema problem with the device material | 8 | 1.9% | 0.2% |
| Migration or expulsion of device | 5 | 1.2% | 5.2% |
| Breakthe device broke | 4 | 0.9% | 0.3% |
| Material split, cut or torn | 4 | 0.9% | 0.1% |
| Fracturea broken bone | 3 | 0.7% | 0% |
| Material twisted/bent | 3 | 0.7% | 0.1% |
| Difficult to removethe device was hard to remove | 2 | 0.5% | 0% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.2% | 0% |
| Improper or incorrect procedure or method | 1 | 0.2% | 0% |
| Manufacturing, packaging or shipping problem | 1 | 0.2% | 0.1% |
| Material frayed | 1 | 0.2% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.2% | 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 |
|---|---|---|
| Painpain, site not specified | 247 | 57.4% |
| Erosion | 133 | 30.9% |
| Urinary tract infectionbladder or urinary infection | 77 | 17.9% |
| Incontinence | 72 | 16.7% |
| Not applicable | 70 | 16.3% |
| Injurya physical injury | 51 | 11.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 38 | 8.8% |
| Discomfortdiscomfort | 31 | 7.2% |
| Micturition urgency | 27 | 6.3% |
| Hemorrhage/blood loss/bleeding | 24 | 5.6% |
| Urinary frequency / polyuria | 24 | 5.6% |
| Abdominal painstomach or belly pain | 21 | 4.9% |
| Ambulation or postural difficulties | 18 | 4.2% |
| Inflammationinflammation | 17 | 4% |
| Urinary retentionbeing unable to empty the bladder | 16 | 3.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Gynecare Tvt Obturator W Lasr | Product code OTN | All MAUDE reports |
|---|---|---|---|
| Reports | 430 | 38,649 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 10 | 9 |
| Classified as injury | 94.7% | 97.4% | 36.2% |
| Classified as malfunction | 5.3% | 1.6% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| 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% |
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 W Lasr reports
How many FDA reports name Gynecare Tvt Obturator W Lasr?
430 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 14 in the latest 12 months.
What kinds of events are reported?
injury (94.7%) and malfunction (5.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration (29.1%), material integrity problem (1.9%), migration or expulsion of device (1.2%), break (0.9%) and material split, cut or torn (0.9%). 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 Gynecare Tvt Obturator W Lasr 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.