Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §862.2050 (Clinical Chemistry panel).
FDA MAUDE casebook
openFDA event book Equipment LIGHT-BOOK · MAUDE
#563 of 1000 · 1,540 reports · 1995–2026
- BOOK 1,540 reports
- RANK #563 of 1000
- DEATH 2 death-typed
- INJ 29 injury-typed
- MALF 1,471 malfunction
- SPAN 1995–2026
- PEAK 2025: 1,253
- PHOTO Toothbrush, Manual
Nearest event-volume peer: Toothbrush, Manual (4 report gap)
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use sits #563 of 1000 among tracked device types with 1,540 MAUDE reports spanning 1995–2026. 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 →
Malfunction reports run above the device-type norm
Equipment carries 95.5% MALFUNCTION-coded reports, 30.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 1.9% corpus 30.3% · below corpus mean (-28.4 pp)
- MALF 95.5% corpus 64.8% · above corpus mean (+30.7 pp)
Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 85% of coded problems · Lead manufacturer BECTON DICKINSON & CO. (SPARKS) accounts for 71% of manufacturer-tagged reports · Top event location is 90% of location-tagged rows .
Equipment in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Modular Elect…
Modular Electromechanical Surgical System
1,552 reports
- Reagent
Reagent, Coronavirus Serological
1,550 reports
- Catheter
Catheter, Umbilical Artery
1,545 reports
- Toothbrush
Toothbrush, Manual
1,544 reports
- Equipment (this)
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
1,540 reports
- Confocal Opti…
Confocal Optical Imaging
1,525 reports
What this shows Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use carries 1,540 MAUDE reports, ranked #563 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 rose to 1,253 in 2025, up from an average of 11 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Top Manufacturers
Event Locations
Compare BECTON DICKINSON & CO. (SPARKS) vs BECTON, DICKINSON & CO. (SPARKS) →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Equipment: 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 (1,540 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Equipment 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 Equipment; 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.