Devices › Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
Device brand name · Surgical mesh
Ams Elevate Anterior Prolapse Repair System With Intepro Lite: medical device reports filed with FDA
202 reports name it, 2014–2016. Manufacturer given most often on reports: American Medical Systems Mn. Product code OTP.
- 202
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1%
- classified as malfunction
- 4.1% across the product code
- 18.3%
- classified as death, as reported
- 37 reports · not verified by FDA
FDA's MAUDE database holds 202 reports that name the brand "Ams Elevate Anterior Prolapse Repair System With Intepro Lite" (surgical mesh), received between January 2014 and September 2016; 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 (80.7%), death (18.3%) and malfunction (1%); across all mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed reports (product code OTP) death is recorded in 2.2% and malfunction in 4.1%. 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 (20.8%), extrusion (9.4%) and malposition of device (2.5%). The patient problems coded most often are pain, urinary retention and death. 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 Elevate Anterior Prolapse Repair System With Intepro Lite was received in the five years to August 2026; the latest was received in September 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 11,655 reports carrying product code OTP. 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 | 42 | 20.8% | 5.2% |
| Extrusion | 19 | 9.4% | 1.2% |
| Malposition of device | 5 | 2.5% | 0.1% |
| Migration or expulsion of device | 4 | 2% | 1.3% |
| Breakthe device broke | 1 | 0.5% | 1.4% |
| Detachment of device or device componentpart of the device came off | 1 | 0.5% | 1.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.5% | 1.5% |
| Disconnection | 1 | 0.5% | 0% |
| Folded | 1 | 0.5% | 0% |
| Material separation | 1 | 0.5% | 0.1% |
| 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 |
|---|---|---|
| Painpain, site not specified | 63 | 31.2% |
| Urinary retentionbeing unable to empty the bladder | 52 | 25.7% |
| Deaththe patient died; cause not stated by this term | 36 | 17.8% |
| Incontinence | 28 | 13.9% |
| Urinary tract infectionbladder or urinary infection | 28 | 13.9% |
| Prolapse | 18 | 8.9% |
| Emotional changes | 14 | 6.9% |
| Injurya physical injury | 13 | 6.4% |
| Urinary frequency / polyuria | 13 | 6.4% |
| Blood loss | 12 | 5.9% |
| Erosion | 12 | 5.9% |
| Internal organ perforation | 11 | 5.4% |
| Micturition urgency | 10 | 5% |
| Discomfortdiscomfort | 8 | 4% |
| Dysuriapain on passing urine | 7 | 3.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ams Elevate Anterior Prolapse Repair System With Intepro Lite | Product code OTP | All MAUDE reports |
|---|---|---|---|
| Reports | 202 | 11,655 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 183 | 22 | 9 |
| Classified as injury | 80.7% | 93.6% | 36.2% |
| Classified as malfunction | 1% | 4.1% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 OTP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Gynecare Prolift Total Pelvic Floor Repair System | 1,187 | 0 | 0.1% |
| Prolift Pelvic Floor Repair | 2,290 | 0 | 0.1% |
| Uphold Lite | 871 | 0 | 0% |
| Pinnacle Pelvic Floor Repair Kits | 2,085 | 0 | 0.1% |
| Uphold Vaginal Support System | 1,861 | 0 | 0.1% |
| Unknown Women's Health Mesh Product | 1,170 | 0 | 0% |
| Gynecare Prolift Anterior Pelvic Floor Repair System | 638 | 0 | 0% |
| Gynecare Prolift Posterior Pelvic Floor Repair System | 370 | 0 | 0% |
| Gynecare Prolift Pelvic Floor Repair System | 313 | 0 | 0% |
| Gynecare Prosima Pelvic Floor Repair System | 309 | 0 | 0% |
| Gynecare Prolift +m Total Pelvic Floor Repair System | 292 | 0 | 0% |
| Prolift Pelvic Floor Repair Unknown Product | 292 | 0 | 0% |
| Prolift +m Pelvic Floor Repair | 525 | 0 | 0.4% |
| Gynecare Prolift +m Anterior Pelvic Floor Repair System | 169 | 0 | 0% |
| 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 Ams Elevate Anterior Prolapse Repair System With Intepro Lite reports
How many FDA reports name Ams Elevate Anterior Prolapse Repair System With Intepro Lite?
202 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 (80.7%), death (18.3%) and malfunction (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (20.8%), extrusion (9.4%), malposition of device (2.5%), migration or expulsion of device (2%) and break (0.5%). 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 Elevate Anterior Prolapse Repair System With Intepro Lite 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.