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TPLC
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show TPLC since
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Device
pad, heating, powered
Product Code
IRT
Regulation Number
890.5740
Device Class
2
MDR Year
MDR Reports
MDR Events
2017
220
220
2018
325
325
2019
205
205
2020
117
117
2021
97
97
2022
24
25
Device Problems
MDRs with this Device Problem
Events in those MDRs
Improper or Incorrect Procedure or Method
218
218
Fire
204
204
Adverse Event Without Identified Device or Use Problem
188
189
Sparking
128
128
Thermal Decomposition of Device
104
104
Smoking
75
75
Break
56
56
Overheating of Device
55
55
Use of Device Problem
55
55
Device Emits Odor
50
50
Insufficient Information
31
31
Material Twisted/Bent
28
28
Bent
27
27
Melted
26
26
Material Discolored
20
20
Material Split, Cut or Torn
20
20
Cut In Material
19
19
Failure to Shut Off
18
18
Crack
18
18
Temperature Problem
18
18
Noise, Audible
16
16
Device Operates Differently Than Expected
15
15
Excessive Heating
13
13
Patient-Device Incompatibility
12
12
Electrical /Electronic Property Problem
9
9
Electrical Shorting
8
8
Naturally Worn
8
8
Material Puncture/Hole
7
7
Inappropriate/Inadequate Shock/Stimulation
7
7
Hole In Material
6
6
Flare or Flash
6
6
Unexpected Therapeutic Results
5
5
Device Inoperable
5
5
Material Protrusion/Extrusion
4
4
Insufficient Heating
4
4
Appropriate Term/Code Not Available
4
4
Patient Device Interaction Problem
3
3
Detachment Of Device Component
3
3
Burst Container or Vessel
3
3
Loss of Power
3
3
Failure to Power Up
3
3
Self-Activation or Keying
3
3
Material Deformation
3
3
Structural Problem
3
3
Folded
3
3
Deformation Due to Compressive Stress
2
2
Split
2
2
Defective Component
2
2
Component Missing
2
2
Detachment of Device or Device Component
2
2
Material Separation
2
2
Device Stops Intermittently
2
2
Nonstandard Device
2
2
Loose or Intermittent Connection
2
2
Fluid Leak
2
2
Therapeutic or Diagnostic Output Failure
2
2
Torn Material
1
1
Unintended Electrical Shock
1
1
Entrapment of Device
1
1
Circuit Failure
1
1
Contamination
1
1
No Display/Image
1
1
Peeled/Delaminated
1
1
Product Quality Problem
1
1
Device Remains Activated
1
1
Material Rupture
1
1
Device Contamination with Chemical or Other Material
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Mechanics Altered
1
1
Output Problem
1
1
Positioning Problem
1
1
Protective Measures Problem
1
1
Scratched Material
1
1
Arcing
1
1
Failure to Cut
1
1
Failure to Advance
1
1
Connection Problem
1
1
Device Packaging Compromised
1
1
Device Unsafe to Use in Environment
1
1
Device-Device Incompatibility
1
1
Device Dislodged or Dislocated
1
1
Electrical Power Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burn(s)
330
331
No Known Impact Or Consequence To Patient
290
290
No Consequences Or Impact To Patient
148
148
Burn, Thermal
56
56
No Information
36
36
Partial thickness (Second Degree) Burn
34
34
No Clinical Signs, Symptoms or Conditions
27
27
Full thickness (Third Degree) Burn
18
18
Insufficient Information
14
14
Electric Shock
12
12
Superficial (First Degree) Burn
11
11
Injury
8
8
No Code Available
3
3
Pain
3
3
Shock
3
3
Death
3
3
Unspecified Infection
3
3
Nerve Damage
2
2
Burning Sensation
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Blister
1
1
Skin Inflammation/ Irritation
1
1
Unspecified Tissue Injury
1
1
Respiratory Acidosis
1
1
Sleep Dysfunction
1
1
Alteration In Body Temperature
1
1
Shock from Patient Lead(s)
1
1
Not Applicable
1
1
Tingling
1
1
Discomfort
1
1
Swelling
1
1
Peeling
1
1
Scarring
1
1
Bruise/Contusion
1
1
Irritation
1
1
Laceration(s)
1
1
Dry Eye(s)
1
1
Electrocution
1
1
Erythema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
2k Innovations Inc.
II
Apr-12-2017
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