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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
2014 2 2
2015 1 1
2016 1 1
2017 4 4
2018 2 2
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 6 6
Insufficient Information 4 4
Patient-Device Incompatibility 4 4
Improper or Incorrect Procedure or Method 1 1
Patient Device Interaction Problem 1 1
Appropriate Term/Code Not Available 1 1
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Anxiety 8 8
Pain 8 8
High Blood Pressure/ Hypertension 6 6
Diarrhea 6 6
Depression 6 6
Weight Changes 5 5
Suicidal Ideation 5 5
Vomiting 5 5
Stroke/CVA 4 4
Convulsion/Seizure 4 4
Toxicity 4 4
Brain Injury 4 4
Sleep Dysfunction 3 3
Headache 3 3
Fatigue 2 2
Metal Related Pathology 2 2
Choking 2 2
Foreign Body Reaction 2 2
Thyroid Problems 1 1
Sensitivity of Teeth 1 1
Constipation 1 1
Tinnitus 1 1
Hypoglycemia 1 1
Peeling 1 1
Hypothermia 1 1
Hair Loss 1 1
Swelling 1 1
Chest Pain 1 1
Palpitations 1 1
Gastritis 1 1
Inflammation 1 1
No Information 1 1
Test Result 1 1
Memory Loss/Impairment 1 1
No Code Available 1 1
Lupus 1 1
Emotional Changes 1 1
Hypersensitivity/Allergic reaction 1 1
Death 1 1
Arrhythmia 1 1
Unspecified Infection 1 1
Abdominal Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Almore International Inc II May-10-2017
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