Devices › Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
Device brand name · Female stress urinary incontinence surgical mesh-sling synthetic polymer
Altis single incision sling system: medical device reports filed with FDA
978 reports name it, 2013–2026. Manufacturer given most often on reports: Coloplast A/S. Product code PAH.
- 978
- device reports naming the brand
- 0% of all MAUDE reports · about 73 a year
- 250
- reports, 12 months to August 2026
- 232 in the 12 months before
- 56%
- classified as malfunction
- 13% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
978 medical device reports received by FDA name the brand "Altis single incision sling system" (female stress urinary incontinence surgical mesh-sling synthetic polymer); the manufacturer given most often on reports is Coloplast A/S; received from February 2013 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
250 reports arrived in the 12 months to August 2026, close to the 232 of 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 malfunction (56%) and injury (44%); across all mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling reports (product code PAH) death is recorded in 1.7% and malfunction in 13%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (39.9%), device dislodged or dislocated (4.5%) and material fragmentation (4.4%). The patient problems coded most often are pain, erosion and urinary 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
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 5,985 reports carrying product code PAH. 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 |
|---|---|---|---|
| Breakthe device broke | 390 | 39.9% | 7.9% |
| Device dislodged or dislocated | 44 | 4.5% | 0.9% |
| Material fragmentation | 43 | 4.4% | 0.7% |
| Device appears to trigger rejection | 38 | 3.9% | 0.7% |
| Material split, cut or torn | 29 | 3% | 0.5% |
| Insufficient device problem information | 24 | 2.5% | 11.2% |
| Detachment of device or device componentpart of the device came off | 22 | 2.2% | 1% |
| Material protrusion/extrusion | 21 | 2.1% | 0.8% |
| Device slipped | 18 | 1.8% | 0.3% |
| Material erosion | 16 | 1.6% | 39.6% |
| Material separation | 16 | 1.6% | 0.3% |
| Migrationthe device moved from where it was placed | 16 | 1.6% | 2.9% |
| Material deformation | 13 | 1.3% | 0.4% |
| Material twisted/bent | 10 | 1% | 0.7% |
| Migration or expulsion of device | 9 | 0.9% | 1.5% |
| Fracturea broken bone | 7 | 0.7% | 0.1% |
| Malposition of device | 7 | 0.7% | 0.3% |
| Improper or incorrect procedure or method | 6 | 0.6% | 0.1% |
| Material frayed | 5 | 0.5% | 0.1% |
| Missing information | 4 | 0.4% | 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 |
|---|---|---|
| Painpain, site not specified | 233 | 23.8% |
| Erosion | 192 | 19.6% |
| Urinary incontinenceleaking urine | 151 | 15.4% |
| Dyspareunia | 142 | 14.5% |
| Urinary tract infectionbladder or urinary infection | 124 | 12.7% |
| Urinary retentionbeing unable to empty the bladder | 90 | 9.2% |
| Micturition urgency | 87 | 8.9% |
| Abnormal vaginal discharge | 80 | 8.2% |
| Dysuriapain on passing urine | 79 | 8.1% |
| Urinary frequency / polyuria | 60 | 6.1% |
| Hematuria | 58 | 5.9% |
| Pelvic pain | 56 | 5.7% |
| Inflammationinflammation | 54 | 5.5% |
| Scar tissue | 48 | 4.9% |
| Hemorrhage/blood loss/bleeding | 43 | 4.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Altis single incision sling system | Product code PAH | All MAUDE reports |
|---|---|---|---|
| Reports | 978 | 5,985 | 26,136,888 |
| Share of that pool | — | 16.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 17 | 9 |
| Classified as injury | 44% | 85.1% | 36.2% |
| Classified as malfunction | 56% | 13% | 62.3% |
| Filed by the manufacturer | 99.5% | 97.3% | 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 PAH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Gynecare Tvt Secur System | 1,732 | 0 | 0% |
| Tension Free Vaginal Tape | 9,355 | 0 | 0.1% |
| Solyx SIS System | 2,031 | 7 | 0.1% |
| T-Sling | 1,108 | 0 | 0% |
| Altis Kit | 369 | 0 | 0% |
| AJUST Adjustable Single-Incision Sling | 186 | 0 | 0% |
| Obtape Transobturator Sling | 1,304 | 0 | 0% |
| Ajust Adjustable Single Incision Sling | 265 | 0 | 0% |
| Miniarc Single-Incision Sling | 327 | 0 | 0% |
| Desara | 919 | 0 | 0% |
| Miniarc Sling System | 183 | 0 | 0.5% |
| Advantage Fit System | 1,496 | 10 | 0.1% |
| Apogee | 261 | 3 | 0.4% |
| Aris Trans-Obturator Kit | 212 | 0 | 0% |
| Avaulta Plus Biosynthetic Support System - Anterior | 241 | 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 Altis single incision sling system reports
How many FDA reports name Altis single incision sling system?
978 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 250 in the latest 12 months.
What kinds of events are reported?
malfunction (56%) and injury (44%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (39.9%), device dislodged or dislocated (4.5%), material fragmentation (4.4%), device appears to trigger rejection (3.9%) and material split, cut or torn (3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Altis single incision 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.