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 Code	OIV
Regulation Number	872.3070
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	7	7
Adverse Event Without Identified Device or Use Problem	2	2
Gas/Air Leak	1	1
Environmental Compatibility Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	4	4
Pain	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Fatigue	3	3
Malaise	3	3
Cognitive Changes	3	3
Anxiety	3	3
Dysphasia	2	2
Weight Changes	2	2
Speech Disorder	2	2
Emotional Changes	2	2
Inflammation	2	2
Tics/Tremor	2	2
Shaking/Tremors	2	2
Toxicity	2	2
Twitching	2	2
Depression	2	2
Unspecified Eye / Vision Problem	2	2
Urinary Tract Infection	1	1
Thyroid Problems	1	1
Swollen Lymph Nodes/Glands	1	1
Tissue Breakdown	1	1
Eczema	1	1
Irritability	1	1
Deformity/ Disfigurement	1	1
Tinnitus	1	1
Headache	1	1
Convulsion/Seizure	1	1
Immunodeficiency	1	1
Myocardial Infarction	1	1
Swelling/ Edema	1	1
Unspecified Tissue Injury	1	1
Hair Loss	1	1
Suicidal Ideation	1	1
Vomiting	1	1
Chest Pain	1	1
Foreign Body In Patient	1	1
Chills	1	1
Confusion/ Disorientation	1	1
Multiple Organ Failure	1	1
Itching Sensation	1	1
Taste Disorder	1	1
Dizziness	1	1
Unspecified Gastrointestinal Problem	1	1
No Code Available	1	1
Fungal Infection	1	1
Nausea	1	1
Failure of Implant	1	1
Death	1	1
Patient Problem/Medical Problem	1	1