Devices › Mesh, surgical, for stress urinary incontinence, male
Device brand name · Surgical mesh
Ams Advance Male Sling System: medical device reports filed with FDA
186 reports name it, 2014–2020. Manufacturer given most often on reports: American Medical Systems Mn. Product code OTM.
- 186
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 3.2%
- classified as malfunction
- 4.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 186 reports that name the brand "Ams Advance Male Sling System" (surgical mesh), received between January 2014 and July 2020; the manufacturer given most often on reports is American Medical Systems Mn. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (96.8%) and malfunction (3.2%); 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 (36.6%), malposition of device (5.4%) and device operates differently than expected (3.8%). The patient problems coded most often are incontinence, erosion and urinary retention. 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
No report naming Ams Advance Male Sling System was received in the five years to August 2026; the latest was received in July 2020.
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 | 68 | 36.6% | 69.4% |
| Malposition of device | 10 | 5.4% | 1.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 7 | 3.8% | 0.9% |
| Breakthe device broke | 5 | 2.7% | 1.5% |
| Migration or expulsion of device | 4 | 2.2% | 0.5% |
| Detachment of device or device componentpart of the device came off | 2 | 1.1% | 0.3% |
| Mechanical problema mechanical problem | 2 | 1.1% | 3.1% |
| Torn material | 2 | 1.1% | 0.3% |
| Defective devicethe device was defective | 1 | 0.5% | 1.8% |
| Device dislodged or dislocated | 1 | 0.5% | 0.3% |
| Device or device fragments location unknown | 1 | 0.5% | 0.1% |
| Difficult to insertthe device was hard to insert | 1 | 0.5% | 0.2% |
| Fluid/blood leak | 1 | 0.5% | 0.1% |
| Material frayed | 1 | 0.5% | 0.1% |
| Material rupture | 1 | 0.5% | 0.1% |
| Unsealed device packaging | 1 | 0.5% | 0.1% |
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 |
|---|---|---|
| Incontinence | 101 | 54.3% |
| Erosion | 20 | 10.8% |
| Urinary retentionbeing unable to empty the bladder | 16 | 8.6% |
| Painpain, site not specified | 11 | 5.9% |
| Injurya physical injury | 5 | 2.7% |
| Perforation | 4 | 2.2% |
| Failure of implant | 3 | 1.6% |
| Internal organ perforation | 3 | 1.6% |
| Abscessa collection of pus | 1 | 0.5% |
| Atrial fibrillationan irregular heart rhythm | 1 | 0.5% |
| Blood loss | 1 | 0.5% |
| Complaint, ill-defined | 1 | 0.5% |
| Discomfortdiscomfort | 1 | 0.5% |
| Distress | 1 | 0.5% |
| Fibrosis | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ams Advance Male Sling System | Product code OTM | All MAUDE reports |
|---|---|---|---|
| Reports | 186 | 1,518 | 26,136,888 |
| Share of that pool | — | 12.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 4 | 9 |
| Classified as injury | 96.8% | 95.3% | 36.2% |
| Classified as malfunction | 3.2% | 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 Sling System | 812 | 8 | 0% |
| AMS AdVance XP Sling System | 221 | 6 | 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 Advance Male Sling System reports
How many FDA reports name Ams Advance Male Sling System?
186 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (96.8%) and malfunction (3.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (36.6%), malposition of device (5.4%), device operates differently than expected (3.8%), break (2.7%) and migration or expulsion of device (2.2%). 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 Advance Male 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.