Injector, Pen
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 §880.5860 (General Hospital panel).
FDA MAUDE casebook
openFDA event book Injector, Pen LIGHT-BOOK · MAUDE
#792 of 1000 · 669 reports · 2004–2026
- BOOK 669 reports
- RANK #792 of 1000
- DEATH 1 death-typed
- INJ 183 injury-typed
- MALF 476 malfunction
- SPAN 2004–2026
- PEAK 2010: 105
- PHOTO Camera
Nearest event-volume peer: Camera, Surgical And Accessories (3 report gap)
Injector, Pen sits #792 of 1000 among tracked device types with 669 MAUDE reports spanning 2004–2026. 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
Injector, Pen carries 71.2% MALFUNCTION-coded reports, 6.3pp 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 27.4% corpus 30.3% · below corpus mean (-2.9 pp)
- MALF 71.2% corpus 64.8% · above corpus mean (+6.3 pp)
Lead product-problem code Break is 17% of coded problems · Lead manufacturer BECTON DICKINSON accounts for 45% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .
Injector, Pen in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Forceps
Forceps, General & Plastic Surgery
673 reports
- Hearing Aid
Hearing Aid, Air-Conduction, Prescription
673 reports
- Camera
Camera, Surgical And Accessories
672 reports
- Single Analyt…
Single (Specified) Analyte Controls (Assayed And Unassayed)
672 reports
- Injector, Pen (this)
Injector, Pen
669 reports
- Endoscope Cha…
Endoscope Channel Accessory
666 reports
What this shows Injector, Pen carries 669 MAUDE reports, ranked #792 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 fell to 7 in 2025, down from an average of 21 in the two years before.
Related Entities for Injector, Pen
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Injector, Pen: 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 (669 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Injector, Pen 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 Injector, Pen; 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.