Devices › Catheter, retention type, balloon
Device brand name · Indwelling urethral drainage balloon catheter non-antimicrobial
Folysil silicone catheter: medical device reports filed with FDA
335 reports name it, 2023–2026. Manufacturer given most often on reports: Coloplast A/S. Product code EZL.
- 335
- device reports naming the brand
- 0% of all MAUDE reports · about 112 a year
- 89
- reports, 12 months to August 2026
- 85 in the 12 months before
- 84.2%
- classified as malfunction
- 86.3% across the product code
- 0.6%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 335 reports that name the brand "Folysil silicone catheter" (indwelling urethral drainage balloon catheter non-antimicrobial), received between July 2023 and August 2026; the manufacturer given most often on reports is Coloplast A/S. Spellings of one product vary from report to report.
89 reports arrived in the 12 months to August 2026, close to the 85 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 (84.2%), injury (15.2%) and death (0.6%); across all catheter, retention type, balloon reports (product code EZL) death is recorded in 0.1% and malfunction in 86.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are burst container or vessel (29%), failure to deflate (13.4%) and unintended deflation (8.4%). The patient problems coded most often are discomfort, urinary retention and pain. 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 9,394 reports carrying product code EZL. 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 |
|---|---|---|---|
| Burst container or vessel | 97 | 29% | 10.8% |
| Failure to deflate | 45 | 13.4% | 1.3% |
| Unintended deflation | 28 | 8.4% | 1.1% |
| Fluid/blood leak | 26 | 7.8% | 8.8% |
| Fracturea broken bone | 16 | 4.8% | 0.8% |
| Device contaminated during manufacture or shipping | 15 | 4.5% | 0.6% |
| Material rupture | 15 | 4.5% | 6.3% |
| Material separation | 12 | 3.6% | 0.3% |
| Improper or incorrect procedure or method | 11 | 3.3% | 0.6% |
| Insufficient device problem information | 10 | 3% | 0.7% |
| Delivered as unsterile product | 9 | 2.7% | 0.2% |
| Obstruction of flow | 8 | 2.4% | 0.8% |
| Complete blockage | 5 | 1.5% | 0.6% |
| No flow | 5 | 1.5% | 0.8% |
| Nonstandard device | 5 | 1.5% | 0.3% |
| Material puncture/hole | 4 | 1.2% | 9.3% |
| Material too rigid or stiff | 4 | 1.2% | 0.2% |
| Crackthe device cracked | 3 | 0.9% | 0.4% |
| Difficult to open or remove packaging material | 3 | 0.9% | 0.1% |
| Difficult to removethe device was hard to remove | 3 | 0.9% | 6.3% |
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 |
|---|---|---|
| Discomfortdiscomfort | 26 | 7.8% |
| Urinary retentionbeing unable to empty the bladder | 22 | 6.6% |
| Painpain, site not specified | 19 | 5.7% |
| Urinary tract infectionbladder or urinary infection | 19 | 5.7% |
| Inflammationinflammation | 4 | 1.2% |
| Pressure sore/ulcer | 4 | 1.2% |
| Hematuria | 3 | 0.9% |
| Necrosisdeath of tissue | 3 | 0.9% |
| Ulcer | 3 | 0.9% |
| Drug resistant bacterial infection | 1 | 0.3% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.3% |
| Hemorrhage/blood loss/bleeding | 1 | 0.3% |
| Internal organ perforation | 1 | 0.3% |
| Intraoperative pain | 1 | 0.3% |
| Sepsisa severe body-wide response to infection | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Folysil silicone catheter | Product code EZL | All MAUDE reports |
|---|---|---|---|
| Reports | 335 | 9,394 | 26,136,888 |
| Share of that pool | — | 3.6% | 0% |
| Classified as death, per 1,000 reports | 6 | 1 | 9 |
| Classified as injury | 15.2% | 13% | 36.2% |
| Classified as malfunction | 84.2% | 86.3% | 62.3% |
| Filed by the manufacturer | 100% | 91.9% | 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 EZL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Bardex Lubri-Sil All-Silicone Foley Catheter | 1,412 | 294 | 0.1% |
| Bardex All-Silicone Foley Catheter | 1,516 | 196 | 0% |
| Bardex Lubri-Sil I.C. All-Silicone Foley Catheter | 3,131 | 620 | 0% |
| Bard Silastic Foley Catheter | 246 | 90 | 0% |
| Bardex Lubri-Sil All-Silicone Temp Sensing Foley Catheter | 248 | 62 | 0% |
| Brillant 2-W Silicone Foley Cylindrical | 248 | 0 | 0% |
| X-Flow prostatectomy catheter | 205 | 97 | 0% |
| Folysil Catheter | 188 | 0 | 0% |
| All Silicone Catheter | 170 | 10 | 0% |
| Bardia All-Silicone Foley Catheter | 176 | 8 | 0% |
| Foley Catheter | 262 | 2 | 0.8% |
| Medline | 26,935 | 26,184 | 0.1% |
| Bard | 1,124 | 2 | 1.8% |
| Surestep | 5,323 | 0 | 0.1% |
| Dover | 171 | 32 | 0.6% |
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 Folysil silicone catheter reports
How many FDA reports name Folysil silicone catheter?
335 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 89 in the latest 12 months.
What kinds of events are reported?
malfunction (84.2%), injury (15.2%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
burst container or vessel (29%), failure to deflate (13.4%), unintended deflation (8.4%), fluid/blood leak (7.8%) and fracture (4.8%). 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 Folysil silicone catheter 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.