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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

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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