Devices › Collector, urine, powered, non indwelling catheter
Device brand name · Purewick
PureWick Urine Collection System: medical device reports filed with FDA
1,494 reports name it, 2020–2026. Manufacturer given most often on reports: C R Bard Covington -1018233. Product code NZU.
- 1,494
- device reports naming the brand
- 0% of all MAUDE reports · about 253 a year
- 1,129
- reports, 12 months to August 2026
- 68 in the 12 months before
- 90.9%
- classified as malfunction
- 51.6% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
1,494 medical device reports received by FDA name the brand "PureWick Urine Collection System" (purewick); the manufacturer given most often on reports is C R Bard Covington -1018233; received from August 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1,129 reports arrived in the 12 months to August 2026, up 1560% from 68 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 (90.9%), injury (9%) and death (0.1%); 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 decrease in suction (77.1%), increase in suction (4.6%) and overheating of device (4.1%). The patient problems coded most often are urinary tract infection, appropriate clinical signs, symptoms and conditions term/code not available and skin inflammation/ irritation. 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 |
|---|---|---|---|
| Decrease in suction | 1,152 | 77.1% | 40% |
| Increase in suction | 69 | 4.6% | 4.6% |
| Overheating of device | 61 | 4.1% | 1.7% |
| Inadequate or insufficient training | 58 | 3.9% | 2.8% |
| Illegible information | 45 | 3% | 1.8% |
| Suction failure | 26 | 1.7% | 1.3% |
| Device handling problem | 20 | 1.3% | 3% |
| Failure to power up | 19 | 1.3% | 0.5% |
| Component missing | 14 | 0.9% | 0.7% |
| Biocompatibility | 13 | 0.9% | 11.5% |
| Missing information | 12 | 0.8% | 0.8% |
| Misassembly by users | 8 | 0.5% | 0.2% |
| Product quality problem | 6 | 0.4% | 0.3% |
| Nonstandard device | 5 | 0.3% | 0.5% |
| Fluid/blood leak | 4 | 0.3% | 3.2% |
| Insufficient device problem information | 3 | 0.2% | 0.3% |
| Patient device interaction problem | 3 | 0.2% | 5.9% |
| Intermittent loss of power | 2 | 0.1% | 0.1% |
| Material fragmentation | 2 | 0.1% | 0.1% |
| Defective devicethe device was defective | 1 | 0.1% | 0.1% |
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 | 70 | 4.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 27 | 1.8% |
| Skin inflammation/ irritation | 22 | 1.5% |
| Pressure sore/ulcer | 18 | 1.2% |
| Painpain, site not specified | 15 | 1% |
| Discomfortdiscomfort | 10 | 0.7% |
| Tissue breakdown | 7 | 0.5% |
| Bruise/contusion | 3 | 0.2% |
| Exposure to body fluids | 3 | 0.2% |
| Local reaction | 3 | 0.2% |
| Rashskin rash | 3 | 0.2% |
| Abrasion | 2 | 0.1% |
| Blistera blister | 2 | 0.1% |
| Electric shockan electric shock | 2 | 0.1% |
| Fungal infectiona fungal infection | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | PureWick Urine Collection System | Product code NZU | All MAUDE reports |
|---|---|---|---|
| Reports | 1,494 | 3,997 | 26,136,888 |
| Share of that pool | — | 37.4% | 0% |
| Classified as death, per 1,000 reports | 1 | 3 | 9 |
| Classified as injury | 9% | 48% | 36.2% |
| Classified as malfunction | 90.9% | 51.6% | 62.3% |
| Filed by the manufacturer | 99.9% | 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 Female External Catheter | 1,178 | 114 | 0.6% |
| 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 Urine Collection System reports
How many FDA reports name PureWick Urine Collection System?
1,494 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,129 in the latest 12 months.
What kinds of events are reported?
malfunction (90.9%), injury (9%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
decrease in suction (77.1%), increase in suction (4.6%), overheating of device (4.1%), inadequate or insufficient training (3.9%) and illegible information (3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that PureWick Urine Collection System 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.