Devices › Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Device brand name · Mesh surgical polymeric
Ams Sparc Sling System: medical device reports filed with FDA
197 reports name it, 2014–2016. Manufacturer given most often on reports: American Medical Systems. Product code OTN.
- 197
- 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
- 1.5%
- classified as malfunction
- 1.6% across the product code
- 68%
- classified as death, as reported
- 134 reports · not verified by FDA
197 medical device reports received by FDA name the brand "Ams Sparc Sling System" (mesh surgical polymeric); the manufacturer given most often on reports is American Medical Systems; received from February 2014 to August 2016. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 death (68%), injury (30.5%) and malfunction (1.5%); 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 insufficient device problem information (55.3%), extrusion (16.8%) and migration or expulsion of device (2%). The patient problems coded most often are death, pain and incontinence. 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 Sparc Sling System was received in the five years to August 2026; the latest was received in August 2016.
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 |
|---|---|---|---|
| Insufficient device problem information | 109 | 55.3% | 8.4% |
| Extrusion | 33 | 16.8% | 0.8% |
| Migration or expulsion of device | 4 | 2% | 5.2% |
| Separation failure | 3 | 1.5% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 1% | 1.1% |
| Material deformation | 2 | 1% | 0.1% |
| Sticking | 2 | 1% | 0% |
| Tear, rip or hole in device packaging | 2 | 1% | 0% |
| Contamination | 1 | 0.5% | 0% |
| Difficult to position | 1 | 0.5% | 0% |
| Disconnection | 1 | 0.5% | 0% |
| Malposition of device | 1 | 0.5% | 0.1% |
| Material fragmentation | 1 | 0.5% | 0% |
| Material integrity problema problem with the device material | 1 | 0.5% | 0.2% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 134 | 68% |
| Painpain, site not specified | 99 | 50.3% |
| Incontinence | 93 | 47.2% |
| Emotional changes | 52 | 26.4% |
| Erosion | 49 | 24.9% |
| Urinary tract infectionbladder or urinary infection | 47 | 23.9% |
| Urinary retentionbeing unable to empty the bladder | 41 | 20.8% |
| Injurya physical injury | 30 | 15.2% |
| Prolapse | 29 | 14.7% |
| Urinary frequency / polyuria | 29 | 14.7% |
| Micturition urgency | 28 | 14.2% |
| Blood loss | 27 | 13.7% |
| Dysuriapain on passing urine | 24 | 12.2% |
| Scarring | 22 | 11.2% |
| Hematuria | 14 | 7.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ams Sparc Sling System | Product code OTN | All MAUDE reports |
|---|---|---|---|
| Reports | 197 | 38,649 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 680 | 10 | 9 |
| Classified as injury | 30.5% | 97.4% | 36.2% |
| Classified as malfunction | 1.5% | 1.6% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| Advantage Fit System | 1,496 | 10 | 0.1% |
| 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% |
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 Sparc Sling System reports
How many FDA reports name Ams Sparc Sling System?
197 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?
death (68%), injury (30.5%) and malfunction (1.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (55.3%), extrusion (16.8%), migration or expulsion of device (2%), separation failure (1.5%) and device operates differently than expected (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 Sparc 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.