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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pad, heating, powered
Product CodeIRT
Regulation Number 890.5740
Device Class 2


Premarket Reviews
ManufacturerDecision
AVACEN INC.
  SUBSTANTIALLY EQUIVALENT 1
DIGITAL HEAT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MIBETEC, GMBH
  SUBSTANTIALLY EQUIVALENT 1
RIEMSER PHARMA
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ANPAN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 414 414
2015 288 288
2016 182 182
2017 220 220
2018 325 325
2019 205 205
2020 117 117
2021 97 97
2022 133 133
2023 322 322
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 404 404
Improper or Incorrect Procedure or Method 336 336
Sparking 267 267
Adverse Event Without Identified Device or Use Problem 237 237
Thermal Decomposition of Device 218 218
Insufficient Information 186 186
Smoking 152 152
Overheating of Device 144 144
Excessive Heating 118 118
Device Emits Odor 98 98
Labelling, Instructions for Use or Training Problem 93 93
Melted 73 73
Break 72 72
Product Quality Problem 67 67
Use of Device Problem 67 67
Temperature Problem 50 50
Failure to Shut Off 46 46
Nonstandard Device 42 42
Device Operates Differently Than Expected 39 39
Crack 32 32
Material Twisted/Bent 28 28
Noise, Audible 28 28
Bent 27 27
Hole In Material 23 23
Material Discolored 22 22
Appropriate Term/Code Not Available 21 21
Material Split, Cut or Torn 20 20
Inappropriate/Inadequate Shock/Stimulation 20 20
Cut In Material 19 19
Electrical /Electronic Property Problem 17 17
Electrical Shorting 14 14
Burst Container or Vessel 13 13
Patient-Device Incompatibility 12 12
Fail-Safe Problem 11 11
Naturally Worn 9 9
Self-Activation or Keying 9 9
Material Puncture/Hole 8 8
Flare or Flash 8 8
Patient Device Interaction Problem 7 7
Insufficient Heating 7 7
Device Remains Activated 7 7
Unexpected Therapeutic Results 6 6
Device Inoperable 6 6
Folded 5 5
Defective Device 5 5
Split 5 5
Arcing 5 5
Loss of Power 5 5
Failure to Power Up 5 5
Energy Output Problem 4 4
Detachment Of Device Component 4 4
Entrapment of Device 4 4
Material Frayed 4 4
Device Stops Intermittently 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Protrusion/Extrusion 4 4
Material Deformation 3 3
Material Integrity Problem 3 3
Human-Device Interface Problem 3 3
Protective Measures Problem 3 3
Torn Material 3 3
Material Separation 3 3
Defective Component 3 3
Structural Problem 3 3
Circuit Failure 3 3
Loose or Intermittent Connection 2 2
Material Rupture 2 2
Fluid/Blood Leak 2 2
Fail-Safe Design Failure 2 2
Charred 2 2
Detachment of Device or Device Component 2 2
Deformation Due to Compressive Stress 2 2
Device Unsafe to Use in Environment 2 2
Component Missing 2 2
Electro-Static Discharge 2 2
No Apparent Adverse Event 2 2
Therapeutic or Diagnostic Output Failure 2 2
Scratched Material 2 2
Mechanics Altered 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Device Damaged by Another Device 2 2
Human Factors Issue 2 2
Output Problem 1 1
Positioning Problem 1 1
Power Problem 1 1
Device Packaging Compromised 1 1
Device Contamination with Chemical or Other Material 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Fail-Safe Did Not Operate 1 1
Key or Button Unresponsive/not Working 1 1
Out-Of-Box Failure 1 1
High Readings 1 1
Device Slipped 1 1
Sticking 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Electrical Power Problem 1 1
Connection Problem 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 712 712
No Known Impact Or Consequence To Patient 678 679
No Consequences Or Impact To Patient 218 218
Insufficient Information 135 135
No Clinical Signs, Symptoms or Conditions 116 116
Partial thickness (Second Degree) Burn 114 114
Burn, Thermal 90 90
No Information 85 85
Full thickness (Third Degree) Burn 77 77
Superficial (First Degree) Burn 36 36
Electric Shock 23 23
Injury 19 19
Pain 17 17
Shock 11 11
Unspecified Infection 10 10
Swelling 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Blister 7 7
Burning Sensation 6 6
Scarring 6 6
Rash 6 6
Erythema 6 6
Death 5 5
Discomfort 4 4
Complaint, Ill-Defined 4 4
Skin Inflammation/ Irritation 4 4
No Code Available 4 4
Not Applicable 3 3
Scar Tissue 3 3
Undesired Nerve Stimulation 3 3
Dry Eye(s) 2 2
Bruise/Contusion 2 2
Nausea 2 2
Nerve Damage 2 2
Skin Burning Sensation 2 2
Shock from Patient Lead(s) 2 2
Impaired Healing 2 2
Reaction 2 2
Confusion/ Disorientation 2 2
Fluid Discharge 1 1
Chemical Exposure 1 1
No Patient Involvement 1 1
No Patient involvement 1 1
Alteration In Body Temperature 1 1
Diaphoresis 1 1
Respiratory Acidosis 1 1
Sleep Dysfunction 1 1
Inadequate Pain Relief 1 1
Deformity/ Disfigurement 1 1
Convulsion/Seizure 1 1
Eye Pain 1 1
Unspecified Tissue Injury 1 1
Rheumatoid Arthritis 1 1
Inflammation 1 1
Irritation 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Dyspnea 1 1
Electrocution 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Incontinence 1 1
Skin Discoloration 1 1
Peeling 1 1
Myalgia 1 1
Tingling 1 1
Dizziness 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 2k Innovations Inc. II Apr-12-2017
2 Battle Creek Equipment Co. II Nov-03-2016
3 Ergoactives, Llc II Jul-07-2016
4 Whele LLC DBA Perch I Nov-23-2022
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