Devices › Mesh, surgical, for stress urinary incontinence, male
Device brand name · Mesh surgical for stress urinary incontinence male
AMS Sling System: medical device reports filed with FDA
812 reports name it, 2018–2026. Manufacturer given most often on reports: Boston Scientific. Product code OTM.
- 812
- device reports naming the brand
- 0% of all MAUDE reports · about 106 a year
- 8
- reports, 12 months to August 2026
- 14 in the 12 months before
- 0.7%
- classified as malfunction
- 4.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
812 medical device reports received by FDA name the brand "AMS Sling System" (mesh surgical for stress urinary incontinence male); the manufacturer given most often on reports is Boston Scientific; received from November 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
8 reports arrived in the 12 months to August 2026, down 43% 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 (99.3%) and malfunction (0.7%); across all mesh, surgical, for stress urinary incontinence, male reports (product code OTM) death is recorded in 0.4% and malfunction in 4.2%. 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 (85.5%), mechanical problem (2.7%) and defective device (1.4%). The patient problems coded most often are urinary incontinence, incontinence and erosion. 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 1,518 reports carrying product code OTM. 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 | 694 | 85.5% | 69.4% |
| Mechanical problema mechanical problem | 22 | 2.7% | 3.1% |
| Defective devicethe device was defective | 11 | 1.4% | 1.8% |
| Breakthe device broke | 1 | 0.1% | 1.5% |
| Device dislodged or dislocated | 1 | 0.1% | 0.3% |
| Fluid/blood leak | 1 | 0.1% | 0.1% |
| Malposition of device | 1 | 0.1% | 1.4% |
| Material twisted/bent | 1 | 0.1% | 0.1% |
| Premature activation | 1 | 0.1% | 0.5% |
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 |
|---|---|---|
| Urinary incontinenceleaking urine | 120 | 14.8% |
| Incontinence | 116 | 14.3% |
| Erosion | 6 | 0.7% |
| Painpain, site not specified | 3 | 0.4% |
| Bacterial infectiona bacterial infection | 1 | 0.1% |
| Device embedded in tissue or plaque | 1 | 0.1% |
| Nerve damage | 1 | 0.1% |
| Pneumonialung infection | 1 | 0.1% |
| Pulmonary embolisma blood clot in the lung | 1 | 0.1% |
| Scar tissue | 1 | 0.1% |
| Sepsisa severe body-wide response to infection | 1 | 0.1% |
| Stroke/cva | 1 | 0.1% |
| Thrombosis | 1 | 0.1% |
| Urinary retentionbeing unable to empty the bladder | 1 | 0.1% |
| Urinary tract infectionbladder or urinary infection | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | AMS Sling System | Product code OTM | All MAUDE reports |
|---|---|---|---|
| Reports | 812 | 1,518 | 26,136,888 |
| Share of that pool | — | 53.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 4 | 9 |
| Classified as injury | 99.3% | 95.3% | 36.2% |
| Classified as malfunction | 0.7% | 4.2% | 62.3% |
| Filed by the manufacturer | 100% | 98.8% | 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 OTM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| AMS AdVance XP Sling System | 221 | 6 | 0% |
| Ams Advance Male Sling System | 186 | 0 | 0% |
| Obtape Transobturator Sling | 1,304 | 0 | 0% |
| Monarc Sling System | 1,247 | 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 AMS Sling System reports
How many FDA reports name AMS Sling System?
812 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 8 in the latest 12 months.
What kinds of events are reported?
injury (99.3%) and malfunction (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (85.5%), mechanical problem (2.7%), defective device (1.4%), break (0.1%) and device dislodged or dislocated (0.1%). 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 AMS Sling 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.