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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
Product CodeIRQ
Regulation Number 890.5950
Device Class 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2018 1 1
2019 7 7
2020 4 4
2021 5 5
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 5 5
Overheating of Device 3 3
Smoking 3 3
Human-Device Interface Problem 3 3
Temperature Problem 2 2
Material Deformation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Thermal Decomposition of Device 1 1
Burst Container or Vessel 1 1
Electrical /Electronic Property Problem 1 1
Use of Device Problem 1 1
Sparking 1 1
Fluid/Blood Leak 1 1
Gel Leak 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
No Patient Involvement 4 4
No Consequences Or Impact To Patient 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Partial thickness (Second Degree) Burn 2 2
Insufficient Information 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Burn, Thermal 1 1
Electric Shock 1 1
Erythema 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, LLC II Mar-27-2012
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