Devices › Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
Device brand name · Mesh surgical synthetic urogynecologic
Gynecare Unknown Product: medical device reports filed with FDA
192 reports name it, 2018–2025. Manufacturer given most often on reports: Ethicon. Product code OTO.
- 192
- device reports naming the brand
- 0% of all MAUDE reports · about 23 a year
- 1
- reports, 12 months to August 2026
- 14 in the 12 months before
- 0%
- classified as malfunction
- 1.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
192 medical device reports received by FDA name the brand "Gynecare Unknown Product" (mesh surgical synthetic urogynecologic); the manufacturer given most often on reports is Ethicon; received from January 2018 to December 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1 reports arrived in the 12 months to August 2026, down 93% from 14 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 (100%); across all mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed reports (product code OTO) death is recorded in 0.5% and malfunction in 1.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration (21.4%), migration or expulsion of device (11.5%) and material erosion (6.3%). The patient problems coded most often are erosion, not applicable 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 4,779 reports carrying product code OTO. 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 | 41 | 21.4% | 4.3% |
| Migration or expulsion of device | 22 | 11.5% | 4.2% |
| Material erosion | 12 | 6.3% | 51.2% |
| Patient-device incompatibilitythe device did not suit the patient | 6 | 3.1% | 0.5% |
| Insufficient device problem information | 4 | 2.1% | 5% |
| Material protrusion/extrusion | 4 | 2.1% | 0.6% |
| Positioning problem | 3 | 1.6% | 0.1% |
| Defective component | 2 | 1% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 1% | 0.5% |
| Malposition of device | 2 | 1% | 0.1% |
| Compatibility problem | 1 | 0.5% | 0% |
| Physical resistance/sticking | 1 | 0.5% | 0% |
| Unintended movement | 1 | 0.5% | 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 |
|---|---|---|
| Erosion | 90 | 46.9% |
| Not applicable | 72 | 37.5% |
| Painpain, site not specified | 46 | 24% |
| Incontinence | 28 | 14.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 17 | 8.9% |
| Urinary tract infectionbladder or urinary infection | 17 | 8.9% |
| Injurya physical injury | 15 | 7.8% |
| Hematomaa collection of blood under the skin or in tissue | 12 | 6.3% |
| Obstruction/occlusion | 12 | 6.3% |
| Hemorrhage/blood loss/bleeding | 8 | 4.2% |
| Prolapse | 8 | 4.2% |
| Micturition urgency | 7 | 3.6% |
| Blood loss | 6 | 3.1% |
| Urinary frequency / polyuria | 6 | 3.1% |
| Abscessa collection of pus | 5 | 2.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Gynecare Unknown Product | Product code OTO | All MAUDE reports |
|---|---|---|---|
| Reports | 192 | 4,779 | 26,136,888 |
| Share of that pool | — | 4% | 0% |
| Classified as death, per 1,000 reports | 0 | 5 | 9 |
| Classified as injury | 100% | 98% | 36.2% |
| Classified as malfunction | 0% | 1.4% | 62.3% |
| Filed by the manufacturer | 100% | 98.7% | 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 OTO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Gynecare Gynemesh Ps | 2,499 | 0 | 0.1% |
| Alyte Y-Mesh Graft | 249 | 3 | 0.4% |
| Gynecare Mesh Unknown | 5,830 | 3 | 0.1% |
| Upsylon | 286 | 10 | 0% |
| Polyform Synthetic Mesh | 546 | 0 | 0.2% |
| Gynecare Gynemsh Ps 4inx6in | 160 | 0 | 0% |
| Gynecare Gynemesh | 216 | 0 | 0% |
| Parietex Ugytex Pp Posterior Kit X1 | 373 | 0 | 0% |
| PROLENE POLYPROPYLENE Mesh | 1,581 | 52 | 0.1% |
| Parietex Ugytex Pp Anterior Kit X1 | 514 | 0 | 0% |
| Gynecare Tvt Oburator System | 1,578 | 0 | 0.1% |
| Unknown Women's Health Product | 2,268 | 0 | 0% |
| Boston Scientific | 580 | 5 | 3.3% |
| Phasix Mesh | 699 | 57 | 0.7% |
| Prosima Pelvic Floor Repair Kit | 316 | 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 Unknown Product reports
How many FDA reports name Gynecare Unknown Product?
192 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.
What kinds of events are reported?
injury (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration (21.4%), migration or expulsion of device (11.5%), material erosion (6.3%), patient-device incompatibility (3.1%) and insufficient device problem information (2.1%). 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 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.