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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, heating, powered
Regulation Description Powered heating unit.
Product CodeIRQ
Regulation Number 890.5950
Device Class 1

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

Device Problems MDRs with this Device Problem Events in those MDRs
Human-Device Interface Problem 3 3
Fire 2 2
Use of Device Problem 1 1
Material Deformation 1 1
No Apparent Adverse Event 1 1
Gel Leak 1 1
Electrical /Electronic Property Problem 1 1
Fluid/Blood Leak 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 2 2
Electric Shock 1 1
Insufficient Information 1 1
Partial thickness (Second Degree) Burn 1 1

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