Devices › Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Device brand name · Mesh surgical synthetic urogynecologic for stress urinary incontinence retr
Advantage Fit System: medical device reports filed with FDA
1,496 reports name it, 2010–2026. Manufacturer given most often on reports: Boston Scientific - Marlborough. Product code OTN.
- 1,496
- device reports naming the brand
- 0% of all MAUDE reports · about 92 a year
- 10
- reports, 12 months to August 2026
- 32 in the 12 months before
- 4.2%
- classified as malfunction
- 1.6% across the product code
- 0.1%
- classified as death, as reported
- 2 reports · not verified by FDA
1,496 medical device reports received by FDA name the brand "Advantage Fit System" (mesh surgical synthetic urogynecologic for stress urinary incontinence retr); the manufacturer given most often on reports is Boston Scientific - Marlborough; received from March 2010 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
10 reports arrived in the 12 months to August 2026, down 69% from 32 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 (95.7%), malfunction (4.2%) 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 positioning problem (1.4%), insufficient device problem information (0.7%) and difficult to advance (0.6%). The patient problems coded most often are pain, erosion and dyspareunia. 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 |
|---|---|---|---|
| Positioning problem | 21 | 1.4% | 0.2% |
| Insufficient device problem information | 11 | 0.7% | 8.4% |
| Difficult to advance | 9 | 0.6% | 0.1% |
| Material deformation | 8 | 0.5% | 0.1% |
| Material twisted/bent | 8 | 0.5% | 0.1% |
| Detachment of device component | 7 | 0.5% | 0.1% |
| Unsealed device packaging | 7 | 0.5% | 0% |
| Defective devicethe device was defective | 6 | 0.4% | 0.1% |
| Material integrity problema problem with the device material | 6 | 0.4% | 0.2% |
| Bent | 5 | 0.3% | 0% |
| Material split, cut or torn | 5 | 0.3% | 0.1% |
| Device packaging compromised | 3 | 0.2% | 0% |
| Material separation | 3 | 0.2% | 0% |
| Packaging problem | 3 | 0.2% | 0% |
| Breakthe device broke | 2 | 0.1% | 0.3% |
| Difficult or delayed positioning | 2 | 0.1% | 0% |
| Difficult to removethe device was hard to remove | 2 | 0.1% | 0% |
| Material puncture/hole | 2 | 0.1% | 0% |
| Tear, rip or hole in device packaging | 2 | 0.1% | 0% |
| Component missing | 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 | 533 | 35.6% |
| Erosion | 260 | 17.4% |
| Dyspareunia | 217 | 14.5% |
| Incontinence | 206 | 13.8% |
| Constipationconstipation | 165 | 11% |
| Abnormal vaginal discharge | 98 | 6.6% |
| Urinary tract infectionbladder or urinary infection | 96 | 6.4% |
| Urinary retentionbeing unable to empty the bladder | 81 | 5.4% |
| Urinary incontinenceleaking urine | 79 | 5.3% |
| Micturition urgency | 68 | 4.5% |
| Scar tissue | 64 | 4.3% |
| Hemorrhage/blood loss/bleeding | 63 | 4.2% |
| Injurya physical injury | 57 | 3.8% |
| Dysuriapain on passing urine | 49 | 3.3% |
| Inflammationinflammation | 46 | 3.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Advantage Fit System | Product code OTN | All MAUDE reports |
|---|---|---|---|
| Reports | 1,496 | 38,649 | 26,136,888 |
| Share of that pool | — | 3.9% | 0% |
| Classified as death, per 1,000 reports | 1 | 10 | 9 |
| Classified as injury | 95.7% | 97.4% | 36.2% |
| Classified as malfunction | 4.2% | 1.6% | 62.3% |
| Filed by the manufacturer | 99.5% | 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% |
| 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% |
| 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 Advantage Fit System reports
How many FDA reports name Advantage Fit System?
1,496 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 10 in the latest 12 months.
What kinds of events are reported?
injury (95.7%), malfunction (4.2%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
positioning problem (1.4%), insufficient device problem information (0.7%), difficult to advance (0.6%), material deformation (0.5%) and material twisted/bent (0.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Advantage Fit System 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.