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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
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 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Labelling, Instructions for Use or Training Problem 125 125
Excessive Heating 120 120
Adverse Event Without Identified Device or Use Problem 89 89
Insufficient Information 74 74
Product Quality Problem 71 71
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
Smoking 11 11
Thermal Decomposition of Device 11 11
Fail-Safe Problem 11 11
Break 10 10
Melted 8 8
Material Twisted/Bent 8 8
Patient Device Interaction Problem 7 7
Patient-Device Incompatibility 6 6
Unexpected Therapeutic Results 5 5
Energy Output Problem 4 4
Material Discolored 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Failure to Shut Off 3 3
Defective Device 2 2
Material Puncture/Hole 2 2
Electrical Shorting 2 2
No Apparent Adverse Event 2 2
Protective Measures Problem 2 2
Naturally Worn 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Electrical /Electronic Property Problem 2 2
Noise, Audible 2 2
Key or Button Unresponsive/not Working 1 1
Failure to Power Up 1 1
Therapeutic or Diagnostic Output Failure 1 1
Component Missing 1 1
Fail-Safe Did Not Operate 1 1
Detachment of Device or Device Component 1 1
Unintended Electrical Shock 1 1
Electrical Power Problem 1 1
Unexpected Shutdown 1 1
Device-Device Incompatibility 1 1
Device Remains Activated 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 361 361
Insufficient Information 143 143
No Clinical Signs, Symptoms or Conditions 124 124
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
Scar Tissue 3 3
Undesired Nerve Stimulation 3 3
Unspecified Infection 2 2
Dry Eye(s) 2 2
Injury 2 2
Discomfort 2 2
Fluid Discharge 2 2
Skin Burning Sensation 2 2
Impaired Healing 1 1
Death 1 1
Diaphoresis 1 1
Dizziness 1 1
No Information 1 1
Itching Sensation 1 1
Myalgia 1 1
Skin Discoloration 1 1
Confusion/ Disorientation 1 1
Irritation 1 1
Erythema 1 1
Nerve Damage 1 1
Unspecified Tissue Injury 1 1
Convulsion/Seizure 1 1
Hemorrhage/Bleeding 1 1
Inadequate Pain Relief 1 1
Eye Pain 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
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