Device brand name · Catheter urethral
L3c0600 - Cure Products: medical device reports filed with FDA
881 reports name it, 2021–2022. Manufacturer given most often on reports: Convatec. Product code EZD.
- 881
- device reports naming the brand
- 0% of all MAUDE reports · about 186 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 88.4%
- classified as malfunction
- 71.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
881 medical device reports received by FDA name the brand "L3c0600 - Cure Products" (catheter urethral); the manufacturer given most often on reports is Convatec; received from October 2021 to July 2022. 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 malfunction (88.4%) and injury (11.6%); across all catheter, straight reports (product code EZD) death is recorded in 0.1% and malfunction in 71.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are defective device (60%), sharp edges (19.1%) and difficult to remove (6.4%). The patient problems coded most often are urinary tract infection, pain and discomfort. 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.
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 4,236 reports carrying product code EZD. 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 |
|---|---|---|---|
| Defective devicethe device was defective | 529 | 60% | 13.7% |
| Sharp edges | 168 | 19.1% | 5.8% |
| Difficult to removethe device was hard to remove | 56 | 6.4% | 4.2% |
| Difficult to open or remove packaging material | 36 | 4.1% | 0.2% |
| Product quality problem | 31 | 3.5% | 12% |
| Insufficient device problem information | 13 | 1.5% | 1.5% |
| Defective component | 9 | 1% | 0.4% |
| Contamination /decontamination problem | 3 | 0.3% | 0.8% |
| Leak/splashthe device leaked | 3 | 0.3% | 0.4% |
| Material integrity problema problem with the device material | 3 | 0.3% | 3.5% |
| Material too soft/flexible | 3 | 0.3% | 0.2% |
| Off-label use | 3 | 0.3% | 0% |
| Device handling problem | 2 | 0.2% | 1% |
| Difficult to insertthe device was hard to insert | 2 | 0.2% | 6.9% |
| Material too rigid or stiff | 2 | 0.2% | 0.3% |
| Unsealed device packaging | 2 | 0.2% | 1.8% |
| Degraded | 1 | 0.1% | 0.1% |
| Delivered as unsterile product | 1 | 0.1% | 1.1% |
| Device misassembled during manufacturing /shipping | 1 | 0.1% | 0.2% |
| Material twisted/bent | 1 | 0.1% | 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 |
|---|---|---|
| Urinary tract infectionbladder or urinary infection | 100 | 11.4% |
| Painpain, site not specified | 71 | 8.1% |
| Discomfortdiscomfort | 7 | 0.8% |
| Hematuria | 7 | 0.8% |
| Fever | 5 | 0.6% |
| Tissue breakdown | 5 | 0.6% |
| Burning sensationa burning feeling | 3 | 0.3% |
| Genital bleeding | 3 | 0.3% |
| Nauseafeeling sick | 3 | 0.3% |
| Abdominal cramps | 2 | 0.2% |
| Headachehead pain | 2 | 0.2% |
| Laceration(s) | 2 | 0.2% |
| Skin tears | 2 | 0.2% |
| Dysuriapain on passing urine | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | L3c0600 - Cure Products | Product code EZD | All MAUDE reports |
|---|---|---|---|
| Reports | 881 | 4,236 | 26,136,888 |
| Share of that pool | — | 20.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 11.6% | 28.1% | 36.2% |
| Classified as malfunction | 88.4% | 71.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 EZD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Magic3 Go Intermittent Urinary Catheter | 830 | 9 | 0% |
| Cure Products | 644 | 1 | 0% |
| Magic3 Go Male Catheter with SureGrip | 470 | 12 | 0% |
| Magic3 Go Male Coude Catheter with SureGrip | 439 | 36 | 0.2% |
| Cure Catheter | 216 | 107 | 0% |
| Intermittent Rochester Catheters | 159 | 0 | 0% |
| Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve | 1,505 | 71 | 0.1% |
| Gentlecath | 402 | 399 | 0% |
| Magic3 Intermittent Catheter | 530 | 11 | 0% |
| Magic3 Intermittent Catheter with Sure-Grip Sleeve | 1,400 | 22 | 0% |
| Bardex I.C. Foley Catheter | 4,010 | 562 | 0% |
| Bardex Lubricath Foley Catheter | 4,923 | 653 | 0% |
| Catheter | 244 | 9 | 3.7% |
| Gentlecath Air | 171 | 136 | 0% |
| Gentlecath Other | 307 | 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 L3c0600 - Cure Products reports
How many FDA reports name L3c0600 - Cure Products?
881 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?
malfunction (88.4%) and injury (11.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
defective device (60%), sharp edges (19.1%), difficult to remove (6.4%), difficult to open or remove packaging material (4.1%) and product quality problem (3.5%). 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 L3c0600 - Cure Products 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.