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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device carver, dental amalgam, operative
Product CodeEKH
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Patient-Device Incompatibility 2 2
Patient Device Interaction Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
High Blood Pressure/ Hypertension 5 5
Diarrhea 5 5
Vomiting 5 5
Depression 5 5
Suicidal Ideation 5 5
Pain 5 5
Anxiety 5 5
Weight Changes 4 4
Stroke/CVA 4 4
Brain Injury 4 4
Convulsion/Seizure 4 4
Metal Related Pathology 2 2
Foreign Body Reaction 2 2
Emotional Changes 1 1
Lupus 1 1
Toxicity 1 1

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