Intrauterine Tamponade Balloon
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §884.4530 (Obstetrics/Gynecology panel).
FDA MAUDE casebook
openFDA event book Intrauterine Tamponade Balloon LIGHT-BOOK · MAUDE
#596 of 1000 · 1,328 reports · 2011–2026
- BOOK 1,328 reports
- RANK #596 of 1000
- DEATH 8 death-typed
- INJ 661 injury-typed
- MALF 657 malfunction
- SPAN 2011–2026
- PEAK 2022: 274
- PHOTO Agent
Nearest event-volume peer: Agent, Occluding, Vascular, Permanent (3 report gap)
Intrauterine Tamponade Balloon sits #596 of 1000 among tracked device types with 1,328 MAUDE reports spanning 2011–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Injury-coded reports run above the device-type norm
Intrauterine Tamponade Balloon carries 49.8% INJURY-coded reports, 19.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
- INJ 49.8% corpus 30.3% · above corpus mean (+19.5 pp)
- MALF 49.5% corpus 64.8% · below corpus mean (-15.4 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 38% of coded problems · Lead manufacturer COOK INC accounts for 99% of manufacturer-tagged reports · Top event location is 75% of location-tagged rows .
Intrauterine Tamponade Balloon in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Implant
Implant, Hearing, Active, Middle Ear, Partially Implanted
1,332 reports
- Intrauterine… (this)
Intrauterine Tamponade Balloon
1,328 reports
- Agent
Agent, Occluding, Vascular, Permanent
1,325 reports
- Stent
Stent, Colonic, Metallic, Expandable
1,319 reports
- Peripheral Me…
Peripheral Mechanical Thrombectomy With Aspiration
1,318 reports
- Pump
Pump, Air, Non-Manual, For Endoscope
1,316 reports
What this shows Intrauterine Tamponade Balloon carries 1,328 MAUDE reports, ranked #596 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (180) held close to the prior two-year average of 222.
Related Entities for Intrauterine Tamponade Balloon
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Intrauterine Tamponade Balloon: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (1,328 here).
Similar death-typed counts
Nearest other device types by death-typed report count (8 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Intrauterine Tamponade Balloon are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Intrauterine Tamponade Balloon; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.