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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
MIBETEC, GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 205 205
2020 117 117
2021 97 97
2022 133 133
2023 322 322
2024 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 121 121
Excessive Heating 118 118
Improper or Incorrect Procedure or Method 109 109
Labelling, Instructions for Use or Training Problem 97 97
Insufficient Information 73 73
Fire 70 70
Product Quality Problem 68 68
Sparking 51 51
Overheating of Device 45 45
Nonstandard Device 40 40
Smoking 39 39
Thermal Decomposition of Device 36 36
Break 28 28
Temperature Problem 28 28
Use of Device Problem 24 24
Appropriate Term/Code Not Available 22 22
Material Split, Cut or Torn 17 17
Material Twisted/Bent 14 14
Melted 14 14
Device Emits Odor 13 13
Fail-Safe Problem 11 11
Noise, Audible 11 11
Failure to Shut Off 10 10
Patient-Device Incompatibility 8 8
Patient Device Interaction Problem 7 7
Naturally Worn 6 6
Electrical Shorting 6 6
Material Puncture/Hole 6 6
Material Discolored 5 5
Unexpected Therapeutic Results 5 5
Energy Output Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Protective Measures Problem 3 3
Defective Device 2 2
Material Protrusion/Extrusion 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Failure to Power Up 2 2
Electrical /Electronic Property Problem 2 2
Self-Activation or Keying 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Component Missing 2 2
Deformation Due to Compressive Stress 2 2
Detachment of Device or Device Component 2 2
Flare or Flash 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Device-Device Incompatibility 1 1
Electrical Power Problem 1 1
Failure to Advance 1 1
Arcing 1 1
Defective Component 1 1
Material Frayed 1 1
Loose or Intermittent Connection 1 1
Device Remains Activated 1 1
Material Rupture 1 1
Peeled/Delaminated 1 1
Loss of Power 1 1
Output Problem 1 1
Material Deformation 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 375 375
Insufficient Information 135 135
No Clinical Signs, Symptoms or Conditions 115 115
No Known Impact Or Consequence To Patient 105 105
No Consequences Or Impact To Patient 63 63
Burn, Thermal 26 26
Partial thickness (Second Degree) Burn 25 25
Superficial (First Degree) Burn 23 23
Full thickness (Third Degree) Burn 15 15
Electric Shock 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Blister 7 7
Pain 5 5
Rash 5 5
Skin Inflammation/ Irritation 4 4
No Information 3 3
Undesired Nerve Stimulation 3 3
Injury 3 3
Scar Tissue 3 3
Skin Burning Sensation 2 2
Death 2 2
Shock 2 2
Unspecified Infection 2 2
Discomfort 2 2
Dry Eye(s) 2 2
Diaphoresis 1 1
Irritation 1 1
Fluid Discharge 1 1
Tingling 1 1
Hemorrhage/Bleeding 1 1
Inadequate Pain Relief 1 1
Itching Sensation 1 1
Dizziness 1 1
Nerve Damage 1 1
Erythema 1 1
Unspecified Tissue Injury 1 1
Myalgia 1 1
Confusion/ Disorientation 1 1
Swelling 1 1
Convulsion/Seizure 1 1
Impaired Healing 1 1
Eye Pain 1 1
Peeling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Whele LLC DBA Perch I Nov-23-2022
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