TPLC - Total Product Life Cycle

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Device	cleanser, denture, over the counter
Regulation Description	OTC denture cleanser.
Product Code	EFT
Regulation Number	872.3520
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	252	252
Patient-Device Incompatibility	10	11
Product Quality Problem	7	7
Appropriate Term/Code Not Available	4	4
Patient Device Interaction Problem	3	3
Improper or Incorrect Procedure or Method	2	2
Labelling, Instructions for Use or Training Problem	1	1
Naturally Worn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	182	182
No Code Available	37	37
Hypersensitivity/Allergic reaction	11	11
Pain	9	9
Discomfort	6	6
Choking	6	6
Burning Sensation	5	5
Abdominal Pain	4	4
Nausea	4	4
No Clinical Signs, Symptoms or Conditions	3	3
Inflammation	3	3
Hemorrhage/Bleeding	3	3
Death	2	2
Dementia	2	2
Cancer	2	2
Sore Throat	2	2
Foreign Body In Patient	2	2
Swelling	2	2
Vomiting	2	2
Numbness	2	2
Swelling/ Edema	2	2
Dyspnea	2	3
Decreased Appetite	1	1
Hallucination	1	1
Ambulation Difficulties	1	1
Bronchitis	1	1
Tissue Breakdown	1	2
Dysgeusia	1	1
Loss of consciousness	1	1
Erosion	1	1
Unspecified Respiratory Problem	1	1
Aphonia	1	1
Hypoxia	1	1
Shock	1	1
Reaction	1	1
Pneumonia	1	1
Laceration(s)	1	1
Salivary Gland Problem	1	1
Erythema	1	1
Diarrhea	1	1
Chest Pain	1	1
Stomach Ulceration	1	1
Fever	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Chemical Exposure	1	1
Cognitive Changes	1	1
Malaise	1	1
Skin Inflammation/ Irritation	1	1
Dizziness	1	1
Memory Loss/Impairment	1	1