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2026 data FDA MAUDE openFDA FDA Class II

Pad, Heating, Powered

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 §890.5740 (Physical Medicine panel).

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FDA MAUDE casebook

openFDA event book Pad, Heating, Powered LIGHT-BOOK · MAUDE

#270 of 1000 · 6,878 reports · 1992–2026

  • BOOK 6,878 reports
  • RANK #270 of 1000
  • DEATH 12 death-typed
  • INJ 1,439 injury-typed
  • MALF 4,826 malfunction
  • SPAN 1992–2026
  • PEAK 2009: 555
  • PHOTO Transcatheter Septal…

Nearest event-volume peer: Transcatheter Septal Occluder (6 report gap)

Pad, Heating, Powered sits #270 of 1000 among tracked device types with 6,878 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 → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Pad, Heating, Powered carries 20.9% INJURY-coded reports, 9.4pp 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 20.9% corpus 30.3% · below corpus mean (-9.4 pp)
  • MALF 70.2% corpus 64.8% · above corpus mean (+5.3 pp)

Lead product-problem code Sparking is 26% of coded problems · Top event location is 76% of location-tagged rows .

Pad, Heating, Powered in the event-volume neighbourhood

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

reports

What this shows Pad, Heating, Powered carries 6,878 MAUDE reports, ranked #270 of 1000.

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

Event Types

Malfunction 4,826 (70.2%)
Injury 1,439 (20.9%)
Other 349 (5.1%)
252 (3.7%)
Death 12 (0.2%)

Patient Outcomes

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

3,841 (54.8%)
Other 2,834 (40.5%)
Required Intervention 99 (1.4%)
R 83 (1.2%)
Hospitalization 59 (0.8%)
O 33 (0.5%)
Life Threatening 15 (0.2%)
S 11 (0.2%)
Death 11 (0.2%)
Disability 10 (0.1%)
L 3 (0.0%)
Congenital Anomaly 3 (0.0%)
H 2 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Sparking 1,925
Thermal Decomposition of Device 1,079
Fire 552
Improper or Incorrect Procedure or Method 547
Smoking 350
Use of Device Problem 311
Insufficient Device Problem Information 303
Overheating of Device 292
Adverse Event Without Identified Device or Use Problem 259
Device Remains Activated 254
Break 203
Labelling, Instructions for Use or Training Problem 175
Device Emits Odor 166
Melted 154
Cut In Material 147
Wire(s), breakage of 133
Excessive Heating 124
Hole In Material 121
Device Inoperable 110
Component(s), broken 108

Yearly Trend

92
1992: 2
93
1993: 4
94
1994: 8
95
1995: 4
96
1996: 120
97
1997: 221
98
1998: 189
99
1999: 190
00
2000: 173
01
2001: 183
02
2002: 231
03
2003: 214
04
2004: 114
05
2005: 132
06
2006: 210
07
2007: 312
08
2008: 242
09
2009: 555
10
2010: 413
11
2011: 227
12
2012: 233
13
2013: 345
14
2014: 414
15
2015: 289
16
2016: 182
17
2017: 220
18
2018: 325
19
2019: 205
20
2020: 117
21
2021: 97
22
2022: 134
23
2023: 321
24
2024: 77
25
2025: 71
26
2026: 104

Reports fell to 71 in 2025, down from an average of 199 in the two years before.

Related Entities for Pad, Heating, Powered

Event Locations

5,204 (75.7%)
I 1,125 (16.4%)
INVALID DATA 224 (3.3%)
HOME 187 (2.7%)
NO INFORMATION 75 (1.1%)
HOSPITAL 39 (0.6%)
UNKNOWN 6 (0.1%)
NOT APPLICABLE 5 (0.1%)
NURSING HOME 5 (0.1%)
OTHER 5 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
BLOOD BANK 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pad, Heating, Powered: 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 (6,878 here).

Transcatheter Septal Occluder 6,884 Prosthesis 6,886 Continuous, Ventilator, Home Use 6,912 Device, Monitoring, Intracranial Pressure 6,841

Similar death-typed counts

Nearest other device types by death-typed report count (12 here), distinct from the volume row.

Adhesive 12 Catheter, Retention Type, Balloon 12 Digital Breast Tomosynthesis 12 Excimer Laser System 12

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

Disclaimer: MAUDE figures for Pad, Heating, Powered 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 Pad, Heating, Powered; 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.