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Pad, Heating, Powered

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FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Pad, Heating, Powered

The FDA MAUDE database aggregates 6,792 adverse-event reports for Pad, Heating, Powered spanning the period from 1992 through 2026. Of these, 12 are classified as death reports, 1,379 as injury reports, and 4,808 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 14 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Fire topping the list at 259 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 555 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 13 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

6,792
Total Reports
12
Death Reports
1,379
Injury Reports
4,808
Malfunctions

Event Types

Malfunction 4,808 (70.8%)
Injury 1,379 (20.3%)
Other 341 (5.0%)
252 (3.7%)
Death 12 (0.2%)

Patient Outcomes

3,827 (55.3%)
Other 2,790 (40.3%)
R 82 (1.2%)
Required Intervention 76 (1.1%)
Hospitalization 59 (0.9%)
O 33 (0.5%)
Life Threatening 14 (0.2%)
S 11 (0.2%)
Death 11 (0.2%)
Disability 9 (0.1%)
L 3 (0.0%)
Congenital Anomaly 3 (0.0%)
H 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Fire 259
Improper or Incorrect Procedure or Method 250
Adverse Event Without Identified Device or Use Problem 234
Labelling, Instructions for Use or Training Problem 154
Insufficient Information 141
Sparking 132
Excessive Heating 125
Thermal Decomposition of Device 125
Overheating of Device 85
Smoking 83
Product Quality Problem 74
Use of Device Problem 67
Break 60
Device Emits Odor 57
Melted 42
Nonstandard Device 42
Temperature Problem 41
Material Twisted/Bent 28
Bent 27
Appropriate Term/Code Not Available 24

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: 18

Related Entities for Pad, Heating, Powered

Event Locations

5,128 (75.5%)
I 1,125 (16.6%)
INVALID DATA 224 (3.3%)
HOME 177 (2.6%)
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%)

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.