Devices › Tubes, gastrointestinal (and accessories)
Device brand name · Fecal management system
Flexi-Seal Fms: medical device reports filed with FDA
195 reports name it, 2005–2013. Manufacturer given most often on reports: Convatec. Product code KNT.
- 195
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 29.7%
- classified as malfunction
- 47% across the product code
- 1.5%
- classified as death, as reported
- 3 reports · not verified by FDA
195 medical device reports received by FDA name the brand "Flexi-Seal Fms" (fecal management system); the manufacturer given most often on reports is Convatec; received from July 2005 to December 2013. 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 injury (60.5%), malfunction (29.7%) and other (7.2%); across all tubes, gastrointestinal (and accessories) reports (product code KNT) death is recorded in 2.4% and malfunction in 47%. 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 (31.3%), deflation problem (9.2%) and inflation problem (6.7%). The patient problems coded most often are hemorrhage/blood loss/bleeding, bleeding and therapy/non-surgical treatment, additional. 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 Flexi-Seal Fms was received in the five years to August 2026; the latest was received in December 2013.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 26,205 reports carrying product code KNT. 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 | 61 | 31.3% | 3.7% |
| Deflation problem | 18 | 9.2% | 2% |
| Inflation problem | 13 | 6.7% | 1.3% |
| Leak/splashthe device leaked | 11 | 5.6% | 4.7% |
| Device, removal of (non-implant) | 10 | 5.1% | 1.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 3.1% | 0.9% |
| Difficult to removethe device was hard to remove | 6 | 3.1% | 4% |
| Fluid/blood leak | 6 | 3.1% | 4.5% |
| Hole in material | 5 | 2.6% | 0.5% |
| Torn material | 5 | 2.6% | 0.5% |
| Breakthe device broke | 4 | 2.1% | 7.5% |
| Detachment of device component | 4 | 2.1% | 4.6% |
| Improper or incorrect procedure or method | 3 | 1.5% | 0.7% |
| Detachment of device or device componentpart of the device came off | 2 | 1% | 3.1% |
| Device dislodged or dislocated | 2 | 1% | 1.4% |
| Device slipped | 2 | 1% | 0.2% |
| Difficult to insertthe device was hard to insert | 2 | 1% | 0.6% |
| Disconnection | 2 | 1% | 1.1% |
| Loss of or failure to bond | 2 | 1% | 0.1% |
| Malposition of device | 2 | 1% | 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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 57 | 29.2% |
| Bleeding | 30 | 15.4% |
| Therapy/non-surgical treatment, additional | 22 | 11.3% |
| Deaththe patient died; cause not stated by this term | 20 | 10.3% |
| Ulcer | 20 | 10.3% |
| Pressure sore/ulcer | 16 | 8.2% |
| Ulceration | 15 | 7.7% |
| Diarrhea | 13 | 6.7% |
| Transfusion of blood products | 12 | 6.2% |
| Hospitalization required | 10 | 5.1% |
| Surgical procedure | 10 | 5.1% |
| Treatment with medication(s) | 8 | 4.1% |
| Anemialow red blood cells | 7 | 3.6% |
| Necrosisdeath of tissue | 6 | 3.1% |
| Erosion | 5 | 2.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Flexi-Seal Fms | Product code KNT | All MAUDE reports |
|---|---|---|---|
| Reports | 195 | 26,205 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 15 | 24 | 9 |
| Classified as injury | 60.5% | 49% | 36.2% |
| Classified as malfunction | 29.7% | 47% | 62.3% |
| Filed by the manufacturer | 100% | 91% | 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 KNT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Duodopa Duopa | 5,925 | 484 | 2% |
| Abbvie Peg | 1,633 | 0 | 1.7% |
| Bard DigniShield Stool Management System | 750 | 94 | 0.7% |
| Kangaroo | 4,328 | 117 | 0.2% |
| EndoVive Safety PEG Kit | 650 | 23 | 0.8% |
| EndoVive Standard PEG Kit | 534 | 15 | 2.1% |
| Corflo Cubby Low Profile Gastrostomy Device | 440 | 0 | 0% |
| Tube Gastrointestinal And Access | 448 | 0 | 1.1% |
| Endovive Jejunal Feeding Tube | 422 | 0 | 0.2% |
| Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit | 333 | 0 | 0.9% |
| Endovive Securi-T | 264 | 0 | 0.4% |
| Abbvie J | 263 | 0 | 6.8% |
| Endovive Two-Port Ttp Jejunal Feeding Tube Cap | 262 | 0 | 1.5% |
| CORTRAK 2 Enteral Access System | 190 | 37 | 14.7% |
| Replacement Tube | 183 | 0 | 0.5% |
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 Flexi-Seal Fms reports
How many FDA reports name Flexi-Seal Fms?
195 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 (60.5%), malfunction (29.7%) and other (7.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (31.3%), deflation problem (9.2%), inflation problem (6.7%), leak/splash (5.6%) and device, removal of (non-implant) (5.1%). 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 Flexi-Seal Fms 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.