Devices › Catheter, nephrostomy, general & plastic surgery
Device brand name · Gbo catheter nephrostomy general & plastic surgery
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter: medical device reports filed with FDA
900 reports name it, 2009–2026. Manufacturer given most often on reports: Cook. Product code GBO.
- 900
- device reports naming the brand
- 0% of all MAUDE reports · about 52 a year
- 58
- reports, 12 months to August 2026
- 61 in the 12 months before
- 57.7%
- classified as malfunction
- 59.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
900 medical device reports received by FDA name the brand "Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter" (gbo catheter nephrostomy general & plastic surgery); the manufacturer given most often on reports is Cook; received from April 2009 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
58 reports arrived in the 12 months to August 2026, close to the 61 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 (57.7%) and injury (42.3%); across all catheter, nephrostomy, general & plastic surgery reports (product code GBO) death is recorded in 0.8% and malfunction in 59.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are leak/splash (19%), material separation (17.9%) and fluid/blood leak (14.6%). The patient problems coded most often are no patient involvement, foreign body in patient 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.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,837 reports carrying product code GBO. 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 171 | 19% | 20.8% |
| Material separation | 161 | 17.9% | 14.1% |
| Fluid/blood leak | 131 | 14.6% | 10.8% |
| Difficult to removethe device was hard to remove | 129 | 14.3% | 11.4% |
| Detachment of device or device componentpart of the device came off | 110 | 12.2% | 5.9% |
| Breakthe device broke | 68 | 7.6% | 8.9% |
| Detachment of device component | 64 | 7.1% | 6.2% |
| Difficult to advance | 17 | 1.9% | 1.9% |
| Component falling | 14 | 1.6% | 0.8% |
| Fitting problem | 14 | 1.6% | 1.4% |
| Disconnection | 13 | 1.4% | 1.5% |
| Obstruction of flow | 10 | 1.1% | 0.8% |
| Device dislodged or dislocated | 9 | 1% | 1% |
| Migration or expulsion of device | 8 | 0.9% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 7 | 0.8% | 0.5% |
| Material deformation | 7 | 0.8% | 1.3% |
| Crackthe device cracked | 6 | 0.7% | 0.7% |
| Device contaminated during manufacture or shipping | 6 | 0.7% | 0.7% |
| Split | 6 | 0.7% | 0% |
| Material integrity problema problem with the device material | 5 | 0.6% | 0.5% |
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 |
|---|---|---|
| No patient involvement | 23 | 2.6% |
| Foreign body in patientpart of a device left in the patient | 19 | 2.1% |
| Discomfortdiscomfort | 8 | 0.9% |
| Pneumothoraxa collapsed lung | 7 | 0.8% |
| Painpain, site not specified | 6 | 0.7% |
| Failure of implant | 5 | 0.6% |
| Device embedded in tissue or plaque | 2 | 0.2% |
| Fistula | 2 | 0.2% |
| Fluid discharge | 2 | 0.2% |
| Blood loss | 1 | 0.1% |
| Bowel perforation | 1 | 0.1% |
| Dehydrationdehydration | 1 | 0.1% |
| Fever | 1 | 0.1% |
| Respiratory distressdifficulty breathing | 1 | 0.1% |
| Urinary retentionbeing unable to empty the bladder | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter | Product code GBO | All MAUDE reports |
|---|---|---|---|
| Reports | 900 | 1,837 | 26,136,888 |
| Share of that pool | — | 49% | 0% |
| Classified as death, per 1,000 reports | 0 | 8 | 9 |
| Classified as injury | 42.3% | 39.8% | 36.2% |
| Classified as malfunction | 57.7% | 59.1% | 62.3% |
| Filed by the manufacturer | 100% | 96.2% | 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 GBO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ultrathane Dawson-Mueller Mac-Loc Locking Loop Multipurpose Drainage Catheter | 687 | 37 | 0.3% |
| Flexima? | 257 | 10 | 0.4% |
| Ultrathane Mac-Loc Locking Loop Biliary Drainage Catheter | 250 | 7 | 1.2% |
| Flexima APDL | 268 | 21 | 1.1% |
| Cook | 271 | 6 | 2.2% |
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 Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter reports
How many FDA reports name Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter?
900 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 58 in the latest 12 months.
What kinds of events are reported?
malfunction (57.7%) and injury (42.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (19%), material separation (17.9%), fluid/blood leak (14.6%), difficult to remove (14.3%) and detachment of device or device component (12.2%). 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 Ultrathane Mac-Loc Locking Loop Multipurpose Drainage 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.