• 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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Excessive Heating 120 120
Labelling, Instructions for Use or Training Problem 118 118
Adverse Event Without Identified Device or Use Problem 89 89
Insufficient Information 74 74
Product Quality Problem 68 68
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
Sparking 15 15
Use of Device Problem 14 14
Device Emits Odor 11 11
Thermal Decomposition of Device 11 11
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
Electrical /Electronic Property Problem 2 2
Electrical Shorting 2 2
Naturally Worn 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Noise, Audible 2 2
Material Puncture/Hole 2 2
Defective Device 2 2
No Apparent Adverse Event 2 2
Unexpected Shutdown 1 1
Key or Button Unresponsive/not Working 1 1
Fail-Safe Did Not Operate 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Electrical Shock 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
Material Frayed 1 1
Component Missing 1 1
Device Remains Activated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 354 354
Insufficient Information 140 140
No Clinical Signs, Symptoms or Conditions 123 123
No Known Impact Or Consequence To Patient 31 31
Superficial (First Degree) Burn 22 22
Partial thickness (Second Degree) Burn 18 18
Full thickness (Third Degree) Burn 15 15
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
Undesired Nerve Stimulation 3 3
Scar Tissue 3 3
Dry Eye(s) 2 2
Unspecified Infection 2 2
Skin Burning Sensation 2 2
Injury 2 2
Fluid Discharge 2 2
Discomfort 2 2
Inadequate Pain Relief 1 1
Skin Discoloration 1 1
Convulsion/Seizure 1 1
Itching Sensation 1 1
No Information 1 1
Erythema 1 1
Irritation 1 1
Dizziness 1 1
Death 1 1
Nerve Damage 1 1
Diaphoresis 1 1
Impaired Healing 1 1
Unspecified Tissue Injury 1 1
Eye Pain 1 1
Hemorrhage/Bleeding 1 1
Myalgia 1 1
Confusion/ Disorientation 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
-
-