Devices › Collector, urine, powered, non indwelling catheter
Device brand name · Purewick female external catheter
PureWick Female External Catheter: medical device reports filed with FDA
1,178 reports name it, 2018–2026. Manufacturer given most often on reports: C R Bard Covington -1018233. Product code NZU.
- 1,178
- device reports naming the brand
- 0% of all MAUDE reports · about 140 a year
- 114
- reports, 12 months to August 2026
- 85 in the 12 months before
- 13%
- classified as malfunction
- 51.6% across the product code
- 0.6%
- classified as death, as reported
- 7 reports · not verified by FDA
FDA's MAUDE database holds 1,178 reports that name the brand "PureWick Female External Catheter" (purewick female external catheter), received between February 2018 and August 2026; the manufacturer given most often on reports is C R Bard Covington -1018233. Spellings of one product vary from report to report.
114 reports arrived in the 12 months to August 2026, up 34% from 85 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 (86.4%), malfunction (13%) and death (0.6%); across all collector, urine, powered, non indwelling catheter reports (product code NZU) death is recorded in 0.3% and malfunction in 51.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are biocompatibility (29.5%), patient device interaction problem (11.5%) and device handling problem (5.9%). The patient problems coded most often are urinary tract infection, skin inflammation/ irritation and rash. 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 3,997 reports carrying product code NZU. 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 |
|---|---|---|---|
| Biocompatibility | 348 | 29.5% | 11.5% |
| Patient device interaction problem | 136 | 11.5% | 5.9% |
| Device handling problem | 70 | 5.9% | 3% |
| Fluid/blood leak | 62 | 5.3% | 3.2% |
| Decrease in suction | 41 | 3.5% | 40% |
| Malposition of device | 35 | 3% | 1.1% |
| Inadequate or insufficient training | 27 | 2.3% | 2.8% |
| Increase in suction | 27 | 2.3% | 4.6% |
| Positioning failure | 24 | 2% | 0.8% |
| Illegible information | 15 | 1.3% | 1.8% |
| Suction failure | 11 | 0.9% | 1.3% |
| Patient-device incompatibilitythe device did not suit the patient | 9 | 0.8% | 1.5% |
| Component misassembled | 7 | 0.6% | 0.3% |
| Device dislodged or dislocated | 5 | 0.4% | 0.3% |
| Nonstandard device | 5 | 0.4% | 0.5% |
| Component missing | 4 | 0.3% | 0.7% |
| Leak/splashthe device leaked | 4 | 0.3% | 0.2% |
| Difficult to removethe device was hard to remove | 3 | 0.3% | 0.1% |
| Incorrect measurementthe device measured wrongly | 3 | 0.3% | 0.1% |
| Missing information | 3 | 0.3% | 0.8% |
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 | 685 | 58.1% |
| Skin inflammation/ irritation | 104 | 8.8% |
| Rashskin rash | 74 | 6.3% |
| Fungal infectiona fungal infection | 51 | 4.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 48 | 4.1% |
| Painpain, site not specified | 35 | 3% |
| Pressure sore/ulcer | 26 | 2.2% |
| Burning sensationa burning feeling | 25 | 2.1% |
| Discomfortdiscomfort | 25 | 2.1% |
| Itching sensation | 17 | 1.4% |
| Bacterial infectiona bacterial infection | 16 | 1.4% |
| Hypersensitivity/allergic reaction | 15 | 1.3% |
| Tissue breakdown | 15 | 1.3% |
| Sepsisa severe body-wide response to infection | 14 | 1.2% |
| Blistera blister | 13 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | PureWick Female External Catheter | Product code NZU | All MAUDE reports |
|---|---|---|---|
| Reports | 1,178 | 3,997 | 26,136,888 |
| Share of that pool | — | 29.5% | 0% |
| Classified as death, per 1,000 reports | 6 | 3 | 9 |
| Classified as injury | 86.4% | 48% | 36.2% |
| Classified as malfunction | 13% | 51.6% | 62.3% |
| Filed by the manufacturer | 98.8% | 99% | 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 NZU
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| PureWick Urine Collection System | 1,494 | 1,129 | 0.1% |
| PureWick Flex Female External Catheter | 272 | 220 | 0% |
| Unknown Purewick Female External Catheter | 151 | 99 | 0.7% |
| Sl Foley Swivel Silicone 25bx | 169 | 0 | 0% |
| All Silicone Catheter | 170 | 10 | 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 PureWick Female External Catheter reports
How many FDA reports name PureWick Female External Catheter?
1,178 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 114 in the latest 12 months.
What kinds of events are reported?
injury (86.4%), malfunction (13%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
biocompatibility (29.5%), patient device interaction problem (11.5%), device handling problem (5.9%), fluid/blood leak (5.3%) and decrease in suction (3.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.8%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that PureWick Female External 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.