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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device amalgamator, dental, ac-powered
Product CodeEFD
Regulation Number 872.3100
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2018 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Complete Blockage 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Electronic Property Issue 1 1
Human Factors Issue 1 1
Infusion or Flow Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Electric Shock 2 2
No Patient Involvement 1 1
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Headache 1 1

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