Devices › Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
Device brand name · Surgical mesh
Altis Kit: medical device reports filed with FDA
369 reports name it, 2014–2019. Manufacturer given most often on reports: Coloplast A/S. Product code PAH.
- 369
- device reports naming the brand
- 0% of all MAUDE reports · about 31 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.9%
- classified as malfunction
- 13% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 369 reports that name the brand "Altis Kit" (surgical mesh), received between July 2014 and December 2019; the manufacturer given most often on reports is Coloplast A/S. 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 (98.1%) and malfunction (1.9%); 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 insufficient device problem information (49.6%), material protrusion/extrusion (6.8%) and migration or expulsion of device (4.6%). The patient problems coded most often are pain, incontinence 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 Altis Kit was received in the five years to August 2026; the latest was received in December 2019.
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 |
|---|---|---|---|
| Insufficient device problem information | 183 | 49.6% | 11.2% |
| Material protrusion/extrusion | 25 | 6.8% | 0.8% |
| Migration or expulsion of device | 17 | 4.6% | 1.5% |
| Material erosion | 16 | 4.3% | 39.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 11 | 3% | 1.4% |
| Breakthe device broke | 10 | 2.7% | 7.9% |
| Extrusion | 8 | 2.2% | 1.3% |
| Device appears to trigger rejection | 5 | 1.4% | 0.7% |
| Positioning problem | 5 | 1.4% | 0.5% |
| Detachment of device component | 4 | 1.1% | 0.3% |
| Device dislodged or dislocated | 3 | 0.8% | 0.9% |
| Difficult to position | 2 | 0.5% | 0.1% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 0.5% | 0.6% |
| Unexpected therapeutic results | 2 | 0.5% | 0.1% |
| Device inoperablethe device could not be used | 1 | 0.3% | 0% |
| Difficult to removethe device was hard to remove | 1 | 0.3% | 0% |
| Fracturea broken bone | 1 | 0.3% | 0.1% |
| Hole in material | 1 | 0.3% | 0% |
| Improper or incorrect procedure or method | 1 | 0.3% | 0.1% |
| Leak/splashthe device leaked | 1 | 0.3% | 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 | 181 | 49.1% |
| Incontinence | 104 | 28.2% |
| Urinary retentionbeing unable to empty the bladder | 61 | 16.5% |
| Urinary tract infectionbladder or urinary infection | 47 | 12.7% |
| Erosion | 46 | 12.5% |
| Micturition urgency | 26 | 7% |
| Blood loss | 23 | 6.2% |
| Dysuriapain on passing urine | 23 | 6.2% |
| Foreign body reaction | 22 | 6% |
| Scarring | 18 | 4.9% |
| Prolapse | 16 | 4.3% |
| Urinary frequency / polyuria | 16 | 4.3% |
| Complaint, ill-defined | 15 | 4.1% |
| Hemorrhage/blood loss/bleeding | 15 | 4.1% |
| Inflammationinflammation | 15 | 4.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Altis Kit | Product code PAH | All MAUDE reports |
|---|---|---|---|
| Reports | 369 | 5,985 | 26,136,888 |
| Share of that pool | — | 6.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 17 | 9 |
| Classified as injury | 98.1% | 85.1% | 36.2% |
| Classified as malfunction | 1.9% | 13% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| Altis single incision sling system | 978 | 250 | 0% |
| Tension Free Vaginal Tape | 9,355 | 0 | 0.1% |
| Solyx SIS System | 2,031 | 7 | 0.1% |
| T-Sling | 1,108 | 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 Kit reports
How many FDA reports name Altis Kit?
369 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 (98.1%) and malfunction (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (49.6%), material protrusion/extrusion (6.8%), migration or expulsion of device (4.6%), material erosion (4.3%) and device operates differently than expected (3%). 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 Altis Kit 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.