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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dental amalgam
Definition Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth
Product CodeOIV
Regulation Number 872.3070
Device Class 2

MDR Year MDR Reports MDR Events
2017 1 1
2018 2 2
2019 1 1
2020 1 1
2021 4 4
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 8 8
Gas/Air Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fatigue 4 5
Cognitive Changes 3 3
Hypersensitivity/Allergic reaction 3 3
Pain 3 3
Myocardial Infarction 2 2
Confusion/ Disorientation 2 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Anxiety 2 2
Toxicity 2 2
Malaise 2 2
Depression 1 1
Fungal Infection 1 1
Neck Pain 1 1
Sleep Dysfunction 1 2
Hair Loss 1 1
Weight Changes 1 1
Tissue Breakdown 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Multiple Organ Failure 1 1
Taste Disorder 1 1
Unspecified Gastrointestinal Problem 1 1
Nausea 1 2
Neuropathy 1 1
Autoimmune Reaction 1 1
Bronchitis 1 2
Death 1 1
Emotional Changes 1 1
Swelling 1 1
Thyroid Problems 1 1
Ulceration 1 1
Urinary Tract Infection 1 1
Vomiting 1 1
Immunodeficiency 1 1
Dizziness 1 1

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