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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bath, paraffin
Regulation Description Paraffin bath.
Product CodeIMC
Regulation Number 890.5110
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 5 5
2024 3 3
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 4 4
Adverse Event Without Identified Device or Use Problem 4 4
No Apparent Adverse Event 2 2
Overheating of Device 2 2
Smoking 1 1
Device Emits Odor 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Burn(s) 2 2
Superficial (First Degree) Burn 1 1
Burn, Thermal 1 1

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