Intrauterine tamponade balloon: medical device reports filed with FDA

1,341 reports carry this product code, 2011–2026; 4 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,341
reports with this product code: 0% of all MAUDE reports; 107
reports, 12 months to August 2026: 209 in the 12 months before; 49.7%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

Product code OQY is FDA's classification for "Intrauterine tamponade balloon" (obstetrics/Gynecology panel), a class 2 device. 1,341 medical device reports carry this product code, 0% of the MAUDE database, from August 2011 to August 2026.

107 reports arrived in the 12 months to August 2026, down 49% from 209 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 (49.7%), injury (49.4%) and death (0.7%). 4 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
JADA System	556	17	1.6%	9.4%
Bakri Tamponade Balloon Catheter	430	34	0%	80.2%
Cook Bakri Postpartum Balloon with Rapid Instillation Components	306	52	0.3%	74.2%
Cook Silicone Balloon Hysterosalpingography Injection Catheter	1	0	0%	97.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Cook	696	51.9%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.7%9

Injury49.4%663

Malfunction49.7%667

Other0.1%1

Not given0.1%1

Who filed

Manufacturer report98%1,314

Voluntary report1%14

User facility report0%0

Distributor report0%0

Not given1%13

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	423	31.5%
Material rupture	96	7.2%
Inflation problem	57	4.3%
Leak/splashthe device leaked	45	3.4%
Detachment of device or device componentpart of the device came off	27	2%
Breakthe device broke	25	1.9%
Material puncture/hole	23	1.7%
Deflation problem	18	1.3%
Component missing	17	1.3%
Improper or incorrect procedure or method	14	1%
Fracturea broken bone	11	0.8%
Material integrity problema problem with the device material	11	0.8%
Suction failure	9	0.7%
Device dislodged or dislocated	8	0.6%
Suction problem	8	0.6%
Obstruction of flow	7	0.5%
Compatibility problem	5	0.4%
Component incompatible	5	0.4%
Component or accessory incompatibility	5	0.4%
Defective component	5	0.4%

Questions about intrauterine tamponade balloon reports

What is product code OQY?

FDA's classification code for "Intrauterine tamponade balloon", class 2, reviewed by the obstetrics/Gynecology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,341 reports through August 2026, 107 of them in the latest 12 months.

Which brands appear most often?

JADA System (556), Bakri Tamponade Balloon Catheter (430), Cook Bakri Postpartum Balloon with Rapid Instillation Components (306) and Cook Silicone Balloon Hysterosalpingography Injection Catheter (1). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.