TPLC - Total Product Life Cycle

show TPLC since

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
Environmental Compatibility Problem	1	1
Gas/Air Leak	1	1

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