Devices › Intrauterine tamponade balloon
Device brand name · Intrauterine vacuum contraction system
JADA System: medical device reports filed with FDA
556 reports name it, 2021–2026. Manufacturer given most often on reports: Organon. Product code OQY.
- 556
- device reports naming the brand
- 0% of all MAUDE reports · about 104 a year
- 17
- reports, 12 months to August 2026
- 93 in the 12 months before
- 9.4%
- classified as malfunction
- 49.7% across the product code
- 1.6%
- classified as death, as reported
- 9 reports · not verified by FDA
FDA's MAUDE database holds 556 reports that name the brand "JADA System" (intrauterine vacuum contraction system), received between March 2021 and August 2026; the manufacturer given most often on reports is Organon. Spellings of one product vary from report to report.
17 reports arrived in the 12 months to August 2026, down 82% from 93 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 (88.8%), malfunction (9.4%) and death (1.6%); 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 break (2%), fracture (2%) and improper or incorrect procedure or method (2%). The patient problems coded most often are hemorrhage/blood loss/bleeding, appropriate clinical signs, symptoms and conditions term/code not available and disseminated intravascular coagulation (dic). 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 |
|---|---|---|---|
| Breakthe device broke | 11 | 2% | 1.9% |
| Fracturea broken bone | 11 | 2% | 0.8% |
| Improper or incorrect procedure or method | 11 | 2% | 1% |
| Material integrity problema problem with the device material | 11 | 2% | 0.8% |
| Suction failure | 9 | 1.6% | 0.7% |
| Suction problem | 7 | 1.3% | 0.6% |
| Obstruction of flow | 6 | 1.1% | 0.5% |
| Compatibility problem | 5 | 0.9% | 0.4% |
| Component incompatible | 5 | 0.9% | 0.4% |
| Component or accessory incompatibility | 5 | 0.9% | 0.4% |
| Expulsion | 5 | 0.9% | 0.4% |
| Inflation problem | 5 | 0.9% | 4.3% |
| Leak/splashthe device leaked | 5 | 0.9% | 3.4% |
| Infusion or flow problema problem with flow or infusion | 4 | 0.7% | 0.4% |
| Mechanical problema mechanical problem | 4 | 0.7% | 0.1% |
| Migration or expulsion of device | 4 | 0.7% | 0.3% |
| Decrease in suction | 3 | 0.5% | 0.3% |
| Therapeutic or diagnostic output failure | 3 | 0.5% | 0.3% |
| Defective devicethe device was defective | 2 | 0.4% | 0.3% |
| Difficult or delayed positioning | 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 | 236 | 42.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 117 | 21% |
| Disseminated intravascular coagulation (dic) | 25 | 4.5% |
| Laceration(s) | 15 | 2.7% |
| Uterine perforationa hole in the wall of the womb | 11 | 2% |
| Low blood pressure/ hypotension | 9 | 1.6% |
| Thrombosis/thrombus | 7 | 1.3% |
| Fever | 6 | 1.1% |
| Coagulation disorder | 4 | 0.7% |
| Wound dehiscencea wound reopened | 4 | 0.7% |
| Coughcough | 3 | 0.5% |
| Abdominal painstomach or belly pain | 2 | 0.4% |
| Abscessa collection of pus | 2 | 0.4% |
| Arthralgiajoint pain | 2 | 0.4% |
| Bacterial infectiona bacterial infection | 2 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | JADA System | Product code OQY | All MAUDE reports |
|---|---|---|---|
| Reports | 556 | 1,341 | 26,136,888 |
| Share of that pool | — | 41.5% | 0% |
| Classified as death, per 1,000 reports | 16 | 7 | 9 |
| Classified as injury | 88.8% | 49.4% | 36.2% |
| Classified as malfunction | 9.4% | 49.7% | 62.3% |
| Filed by the manufacturer | 99.6% | 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 |
|---|---|---|---|
| Bakri Tamponade Balloon Catheter | 509 | 34 | 0% |
| 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 JADA System reports
How many FDA reports name JADA System?
556 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 17 in the latest 12 months.
What kinds of events are reported?
injury (88.8%), malfunction (9.4%) and death (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (2%), fracture (2%), improper or incorrect procedure or method (2%), material integrity problem (2%) and suction failure (1.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) 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 JADA 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.