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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device saw
Product CodeHSO
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 2 2
2019 3 3
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Moisture Damage 2 2
Leak/Splash 1 1
Contamination 1 1
Component Missing 1 1
Improper or Incorrect Procedure or Method 1 1
Hot Oil Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Not Applicable 3 3
No Information 2 2
No Patient Involvement 2 2
Foreign Body In Patient 1 1

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