Devices › Intrauterine tamponade balloon
Device brand name · Oqy intrauterine balloon
Bakri Tamponade Balloon Catheter: medical device reports filed with FDA
509 reports name it, 2010–2026. Manufacturer given most often on reports: Cook. Product code OQY.
- 509
- device reports naming the brand
- 0% of all MAUDE reports · about 31 a year
- 34
- reports, 12 months to August 2026
- 78 in the 12 months before
- 80.2%
- classified as malfunction
- 49.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 509 reports that name the brand "Bakri Tamponade Balloon Catheter" (oqy intrauterine balloon), received between March 2010 and August 2026; the manufacturer given most often on reports is Cook. Spellings of one product vary from report to report.
34 reports arrived in the 12 months to August 2026, down 56% from 78 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 (80.2%) and injury (19.8%); across all intrauterine tamponade balloon reports (product code OQY) death is recorded in 0.7% and malfunction in 49.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (51.1%), material rupture (13.4%) and leak/splash (11.2%). The patient problems coded most often are hemorrhage/blood loss/bleeding, blood loss and no patient involvement. 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 1,341 reports carrying product code OQY. 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 |
|---|---|---|---|
| Fluid/blood leak | 260 | 51.1% | 31.5% |
| Material rupture | 68 | 13.4% | 7.2% |
| Leak/splashthe device leaked | 57 | 11.2% | 3.4% |
| Inflation problem | 19 | 3.7% | 4.3% |
| Material puncture/hole | 18 | 3.5% | 1.7% |
| Detachment of device or device componentpart of the device came off | 17 | 3.3% | 2% |
| Deflation problem | 14 | 2.8% | 1.3% |
| Breakthe device broke | 8 | 1.6% | 1.9% |
| Component missing | 7 | 1.4% | 1.3% |
| Device dislodged or dislocated | 7 | 1.4% | 0.6% |
| Hole in material | 6 | 1.2% | 0.1% |
| Device contaminated during manufacture or shipping | 3 | 0.6% | 0.1% |
| Device slipped | 3 | 0.6% | 0.1% |
| Blocked connection | 2 | 0.4% | 0.1% |
| Burst container or vessel | 2 | 0.4% | 0.1% |
| Defective component | 2 | 0.4% | 0.4% |
| Device damaged prior to usethe device was damaged before use | 2 | 0.4% | 0.2% |
| Loose or intermittent connection | 2 | 0.4% | 0.1% |
| Split | 2 | 0.4% | 0% |
| Unintended deflation | 2 | 0.4% | 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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 42 | 8.3% |
| Blood loss | 14 | 2.8% |
| No patient involvement | 6 | 1.2% |
| Foreign body in patientpart of a device left in the patient | 5 | 1% |
| Uterine perforationa hole in the wall of the womb | 3 | 0.6% |
| Hypovolemic shock | 2 | 0.4% |
| Low blood pressure/ hypotension | 2 | 0.4% |
| Pelvic pain | 2 | 0.4% |
| Swelling/ edema | 2 | 0.4% |
| Abdominal painstomach or belly pain | 1 | 0.2% |
| Bacterial infectiona bacterial infection | 1 | 0.2% |
| Coagulation disorder | 1 | 0.2% |
| Fever | 1 | 0.2% |
| Infertilitydifficulty conceiving | 1 | 0.2% |
| Intermenstrual bleeding | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bakri Tamponade Balloon Catheter | Product code OQY | All MAUDE reports |
|---|---|---|---|
| Reports | 509 | 1,341 | 26,136,888 |
| Share of that pool | — | 38% | 0% |
| Classified as death, per 1,000 reports | 0 | 7 | 9 |
| Classified as injury | 19.8% | 49.4% | 36.2% |
| Classified as malfunction | 80.2% | 49.7% | 62.3% |
| Filed by the manufacturer | 99.8% | 98% | 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 OQY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| JADA System | 556 | 17 | 1.6% |
| Cook Bakri Postpartum Balloon with Rapid Instillation Components | 361 | 52 | 0.3% |
| Cook Silicone Balloon Hysterosalpingography Injection Catheter | 169 | 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 Bakri Tamponade Balloon Catheter reports
How many FDA reports name Bakri Tamponade Balloon Catheter?
509 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 34 in the latest 12 months.
What kinds of events are reported?
malfunction (80.2%) and injury (19.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (51.1%), material rupture (13.4%), leak/splash (11.2%), inflation problem (3.7%) and material puncture/hole (3.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bakri Tamponade Balloon 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.