• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device pad, heating, powered
Regulation Description Powered heating pad.
Product CodeIRT
Regulation Number 890.5740
Device Class 2


Premarket Reviews
ManufacturerDecision
MIBETEC, GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 117 117
2021 97 97
2022 133 133
2023 322 322
2024 77 77
2025 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Labelling, Instructions for Use or Training Problem 135 135
Excessive Heating 121 121
Adverse Event Without Identified Device or Use Problem 89 89
Insufficient Information 77 77
Product Quality Problem 72 72
Improper or Incorrect Procedure or Method 49 49
Fire 43 43
Nonstandard Device 40 40
Overheating of Device 25 25
Temperature Problem 23 23
Appropriate Term/Code Not Available 20 20
Use of Device Problem 16 16
Sparking 15 15
Device Emits Odor 12 12
Thermal Decomposition of Device 12 12
Smoking 11 11
Fail-Safe Problem 11 11
Break 10 10
Material Twisted/Bent 8 8
Melted 8 8
Patient Device Interaction Problem 7 7
Patient-Device Incompatibility 6 6
Unexpected Therapeutic Results 5 5
Energy Output Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Material Discolored 3 3
Failure to Shut Off 3 3
Protective Measures Problem 2 2
No Apparent Adverse Event 2 2
Naturally Worn 2 2
Noise, Audible 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Electrical /Electronic Property Problem 2 2
Electrical Shorting 2 2
Material Puncture/Hole 2 2
Defective Device 2 2
Therapeutic or Diagnostic Output Failure 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
Material Frayed 1 1
Component Missing 1 1
Insufficient Heating 1 1
Electrical Power Problem 1 1
Device-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Failure to Power Up 1 1
Device Remains Activated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 370 370
Insufficient Information 148 148
No Clinical Signs, Symptoms or Conditions 126 126
No Known Impact Or Consequence To Patient 31 31
Superficial (First Degree) Burn 23 23
Partial thickness (Second Degree) Burn 19 19
Full thickness (Third Degree) Burn 16 16
No Consequences Or Impact To Patient 14 14
Burn, Thermal 9 9
Blister 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Pain 6 6
Electric Shock 5 5
Rash 5 5
Skin Inflammation/ Irritation 4 4
Scar Tissue 3 3
Undesired Nerve Stimulation 3 3
Dry Eye(s) 2 2
Unspecified Infection 2 2
Discomfort 2 2
Injury 2 2
Fluid Discharge 2 2
Skin Burning Sensation 2 2
Eye Pain 1 1
Convulsion/Seizure 1 1
No Information 1 1
Dizziness 1 1
Skin Discoloration 1 1
Nerve Damage 1 1
Itching Sensation 1 1
Irritation 1 1
Unspecified Tissue Injury 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Confusion/ Disorientation 1 1
Eye Burn 1 1
Diaphoresis 1 1
Inadequate Pain Relief 1 1
Impaired Healing 1 1
Myalgia 1 1
Hemorrhage/Bleeding 1 1
Erythema 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 EYE COMFORT CARE LLC II Aug-14-2024
2 Whele LLC DBA Perch I Nov-23-2022
-
-