PlainHospital
2026 data FDA MAUDE openFDA

Electrode, Cutaneous

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Electrode, Cutaneous LIGHT-BOOK · MAUDE

#865 of 1000 · 505 reports · 1995–2026

  • BOOK 505 reports
  • RANK #865 of 1000
  • DEATH 1 death-typed
  • INJ 214 injury-typed
  • MALF 207 malfunction
  • SPAN 1995–2026
  • PEAK 2024: 60
  • PHOTO Cutter, Wire

Nearest event-volume peer: Cutter, Wire (0 report gap)

Electrode, Cutaneous sits #865 of 1000 among tracked device types with 505 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 42.4% corpus 30.4% · above corpus mean (+11.9 pp)
  • MALF 41.0% corpus 64.5% · below corpus mean (-23.5 pp)

Lead product-problem code Patient Device Interaction Problem is 20% of coded problems · Lead manufacturer COVIDIEN accounts for 100% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Electrode, Cutaneous in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Electrode, Cutaneous carries 505 MAUDE reports, ranked #865 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 214 (42.4%)
Malfunction 207 (41.0%)
Other 72 (14.3%)
11 (2.2%)
Death 1 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

212 (41.2%)
Other 202 (39.3%)
Required Intervention 77 (15.0%)
Hospitalization 9 (1.8%)
R 5 (1.0%)
Disability 3 (0.6%)
S 2 (0.4%)
L 1 (0.2%)
O 1 (0.2%)
Death 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Patient Device Interaction Problem 55
Patient-Device Incompatibility 39
Adverse Event Without Identified Device or Use Problem 37
Low Readings 25
High Readings 23
Incorrect Measurement 17
Unable to Obtain Readings 16
Insufficient Information 9
Improper or Incorrect Procedure or Method 8
Use of Device Problem 8
Communication or Transmission Problem 7
Device Operates Differently Than Expected 7
Image Display Error/Artifact 7
Temperature Problem 5
Incorrect, Inadequate or Imprecise Result or Readings 4
Defective Component 3
Erratic or Intermittent Display 3
Failure to Analyze Signal 3
Material Separation 3
Sharp Edges 3

Yearly Trend

95
1995: 4
96
1996: 1
97
1997: 4
98
1998: 5
99
1999: 2
00
2000: 11
01
2001: 5
02
2002: 7
03
2003: 11
04
2004: 18
05
2005: 10
06
2006: 11
07
2007: 14
08
2008: 17
09
2009: 15
10
2010: 14
11
2011: 16
12
2012: 16
13
2013: 15
14
2014: 11
15
2015: 19
16
2016: 15
17
2017: 11
18
2018: 10
19
2019: 19
20
2020: 11
21
2021: 21
22
2022: 34
23
2023: 29
24
2024: 60
25
2025: 59
26
2026: 10

Related Entities for Electrode, Cutaneous

Top Manufacturers

COVIDIEN 52

Event Locations

351 (69.5%)
I 83 (16.4%)
HOSPITAL 42 (8.3%)
OUTPATIENT TREATMENT FACILITY 10 (2.0%)
HOME 8 (1.6%)
NO INFORMATION 4 (0.8%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.4%)
UNKNOWN 2 (0.4%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
INVALID DATA 1 (0.2%)
OTHER 1 (0.2%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Electrode, Cutaneous, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (505 here).

Cutter, Wire 505 Total 505 Bur, Dental 504 Stylet, Tracheal Tube 504

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Electrode, Cutaneous 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 Electrode, Cutaneous; 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.