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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §882.1320 (Neurology panel).

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FDA MAUDE casebook

openFDA event book Electrode, Cutaneous LIGHT-BOOK · MAUDE

#871 of 1000 · 529 reports · 1995–2026

  • BOOK 529 reports
  • RANK #871 of 1000
  • DEATH 1 death-typed
  • INJ 220 injury-typed
  • MALF 225 malfunction
  • SPAN 1995–2026
  • PEAK 2025: 59
  • PHOTO Serology Tests Used F…

Nearest event-volume peer: Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations (2 report gap)

Electrode, Cutaneous sits #871 of 1000 among tracked device types with 529 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 sit below the device-type norm

Electrode, Cutaneous carries 42.5% MALFUNCTION-coded reports, 22.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 41.6% corpus 30.3% · above corpus mean (+11.3 pp)
  • MALF 42.5% corpus 64.8% · below corpus mean (-22.3 pp)

Lead product-problem code Unknown (for use when the device problem is not known) is 14% of coded problems · Lead manufacturer COVIDIEN accounts for 100% of manufacturer-tagged reports · Top event location is 71% 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 529 MAUDE reports, ranked #871 of 1000.

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

Event Types

Malfunction 225 (42.5%)
Injury 220 (41.6%)
Other 72 (13.6%)
11 (2.1%)
Death 1 (0.2%)

Patient Outcomes

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

219 (41.3%)
Other 205 (38.7%)
Required Intervention 83 (15.7%)
Hospitalization 9 (1.7%)
R 6 (1.1%)
Disability 3 (0.6%)
S 2 (0.4%)
L 1 (0.2%)
Death 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Unknown (for use when the device problem is not known) 67
Patient Device Interaction Problem 59
Insufficient Device Problem Information 53
Adverse Event Without Identified Device or Use Problem 50
Patient-Device Incompatibility 47
High Readings 27
Low Readings 26
Incorrect Measurement 24
Unable to Obtain Readings 19
Device Operates Differently Than Expected 15
Use of Device Problem 15
Communication or Transmission Problem 11
Device-Device Incompatibility 11
Improper or Incorrect Procedure or Method 11
Reaction 11
Material Separation 8
Image Display Error/Artifact 7
Smoking 7
Temperature Problem 7
Incorrect, Inadequate or Imprecise Result or Readings 6

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: 25
24
2024: 51
25
2025: 59
26
2026: 47

Reports rose to 59 in 2025, up from an average of 38 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Electrode, Cutaneous

Top Manufacturers

COVIDIEN 66

Event Locations

374 (70.7%)
I 83 (15.7%)
HOSPITAL 43 (8.1%)
OUTPATIENT TREATMENT FACILITY 10 (1.9%)
HOME 8 (1.5%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Electrode, Cutaneous: 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 (529 here).

Serology Tests Used For Infectious Disease… 527 Drug-Coated Peripheral Transluminal Angiopl… 526 Display, Cathode-Ray Tube, Medical 525 Culture Media 534

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.