Devices › Mesh, surgical, polymeric
Device brand name · Puboruethral support tape
Aris Trans-Obturator Kit: medical device reports filed with FDA
212 reports name it, 2012–2020. Manufacturer given most often on reports: Coloplast A/S. Product code FTL.
- 212
- 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
- 1.4%
- classified as malfunction
- 2.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 212 reports that name the brand "Aris Trans-Obturator Kit" (puboruethral support tape), received between January 2012 and June 2020; 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 (98.6%) and malfunction (1.4%); across all mesh, surgical, polymeric reports (product code FTL) death is recorded in 0.5% and malfunction in 2.5%. 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 (67%), extrusion (9%) and material erosion (4.2%). The patient problems coded most often are pain, injury and erosion. 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 Aris Trans-Obturator Kit was received in the five years to August 2026; the latest was received in June 2020.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 170,304 reports carrying product code FTL. 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 | 142 | 67% | 26.3% |
| Extrusion | 19 | 9% | 0.8% |
| Material erosion | 9 | 4.2% | 5.4% |
| Patient-device incompatibilitythe device did not suit the patient | 6 | 2.8% | 7.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 4 | 1.9% | 1.2% |
| Migration or expulsion of device | 3 | 1.4% | 4% |
| Device appears to trigger rejection | 2 | 0.9% | 0.2% |
| Entrapment of device | 1 | 0.5% | 0.3% |
| Material deformation | 1 | 0.5% | 2.3% |
| Material protrusion/extrusion | 1 | 0.5% | 0.2% |
| Material separation | 1 | 0.5% | 0.2% |
| Material too rigid or stiff | 1 | 0.5% | 0% |
| Material twisted/bent | 1 | 0.5% | 0% |
| Positioning problem | 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 | 164 | 77.4% |
| Injurya physical injury | 90 | 42.5% |
| Erosion | 55 | 25.9% |
| Emotional changes | 39 | 18.4% |
| Disability | 31 | 14.6% |
| Incontinence | 31 | 14.6% |
| Deformity/ disfigurement | 30 | 14.2% |
| Therapeutic response, decreased | 14 | 6.6% |
| Urinary tract infectionbladder or urinary infection | 11 | 5.2% |
| Autoimmune disorder | 10 | 4.7% |
| Hemorrhage/blood loss/bleeding | 10 | 4.7% |
| Urinary frequency / polyuria | 7 | 3.3% |
| Prolapse | 6 | 2.8% |
| Abdominal painstomach or belly pain | 5 | 2.4% |
| Abnormal vaginal discharge | 5 | 2.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Aris Trans-Obturator Kit | Product code FTL | All MAUDE reports |
|---|---|---|---|
| Reports | 212 | 170,304 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 5 | 9 |
| Classified as injury | 98.6% | 96.5% | 36.2% |
| Classified as malfunction | 1.4% | 2.5% | 62.3% |
| Filed by the manufacturer | 100% | 97.4% | 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 FTL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Bard Flat Mesh | 8,299 | 110 | 0.5% |
| PerFix Plug | 8,256 | 167 | 0.3% |
| Parietex | 6,304 | 320 | 1% |
| Ventralight ST Mesh | 5,813 | 106 | 0.5% |
| Obtryx System | 6,031 | 1 | 0% |
| Ventralex ST | 5,365 | 101 | 0.4% |
| Tension Free Vaginal Tape | 9,355 | 0 | 0.1% |
| Mesh Ventralex | 4,661 | 5 | 0.4% |
| 3DMax | 3,971 | 155 | 0.1% |
| ProGrip | 3,820 | 412 | 0.8% |
| Proceed Surg Mesh/Multi Lyr | 3,199 | 29 | 0% |
| Mesh Sofradim - Parietex Composite Mesh | 2,946 | 16 | 1.5% |
| Advantage? System | 3,537 | 13 | 0% |
| Ventrio ST | 2,751 | 51 | 0.7% |
| Symbotex | 2,741 | 190 | 1.2% |
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 Aris Trans-Obturator Kit reports
How many FDA reports name Aris Trans-Obturator Kit?
212 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 (98.6%) and malfunction (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (67%), extrusion (9%), material erosion (4.2%), patient-device incompatibility (2.8%) and device operates differently than expected (1.9%). 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 Aris Trans-Obturator 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.