Tube Tracheostomy And Tube Cuff
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 §868.5800 (Anesthesiology panel).
FDA MAUDE casebook
openFDA event book Tube Tracheostomy And Tube Cuff MID-BOOK · MAUDE
#172 of 1000 · 14,927 reports · 1992–2026
- BOOK 14,927 reports
- RANK #172 of 1000
- DEATH 164 death-typed
- INJ 5,185 injury-typed
- MALF 9,526 malfunction
- SPAN 1992–2026
- PEAK 2022: 1,632
- PHOTO Pump
Nearest event-volume peer: Pump, Infusion, Enteral (15 report gap)
Tube Tracheostomy And Tube Cuff sits #172 of 1000 among tracked device types with 14,927 MAUDE reports spanning 1992–2026. 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
Tube Tracheostomy And Tube Cuff carries 34.7% INJURY-coded reports, 4.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
- INJ 34.7% corpus 30.3% · above corpus mean (+4.4 pp)
- MALF 63.8% corpus 64.8% · below corpus mean (-1.0 pp)
Lead product-problem code Inflation Problem is 15% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 51% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .
Tube Tracheostomy And Tube Cuff in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Tube Tracheos… (this)
Tube Tracheostomy And Tube Cuff
14,927 reports
- Pump
Pump, Infusion, Enteral
14,912 reports
- Lift
Lift, Patient, Non-Ac-Powered
14,697 reports
- Appliance
Appliance, Fixation, Spinal Interlaminal
14,567 reports
- Pulse Generat…
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
14,494 reports
- Device
Device, Vascular, For Promoting Embolization
14,423 reports
What this shows Tube Tracheostomy And Tube Cuff carries 14,927 MAUDE reports, ranked #172 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 (998) held close to the prior two-year average of 1,168.
Related Entities for Tube Tracheostomy And Tube Cuff
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Tube Tracheostomy And Tube Cuff: 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 (14,927 here).
Similar death-typed counts
Nearest other device types by death-typed report count (164 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Tube Tracheostomy And Tube Cuff 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 Tube Tracheostomy And Tube Cuff; 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.