TPLC - Total Product Life Cycle

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Device	rinse, oral, antibacterial (by physical means)
Definition	Antibacterial oral rinse that is used as an aid in the treatment of gingivitis, acting by physical rather than chemical means. The rinse works by coating tooth and tissue surfaces, providing a positive charge that reduces bacterial adhesion.
Product Code	NTO
Regulation Number	872.5580
Device Class	2

MDR Year	MDR Reports	MDR Events
2020	1	1
2021	23	23

Device Problems	MDRs with this Device Problem	Events in those MDRs
Nonstandard Device	14	14
Patient-Device Incompatibility	6	6
Contamination	3	3
Microbial Contamination of Device	2	2
Patient Device Interaction Problem	1	1
Product Quality Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	6	6
Dyspnea	4	4
Unspecified Infection	3	3
No Clinical Signs, Symptoms or Conditions	3	3
Nausea	2	2
Numbness	2	2
Chest Pain	2	2
Cough	2	2
Hypoxia	2	2
Unspecified Respiratory Problem	2	2
Bacterial Infection	2	2
Skin Infection	1	1
Skin Inflammation/ Irritation	1	1
Taste Disorder	1	1
Inflammation	1	1
Local Reaction	1	1
Skin Disorders	1	1
Fever	1	1
Rash	1	1
Discomfort	1	1
Pain	1	1
Pneumonia	1	1
Swelling/ Edema	1	1
Ulcer	1	1
Sore Throat	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1
Low Oxygen Saturation	1	1
Sensitivity of Teeth	1	1
Respiratory Failure	1	1
Increased Sensitivity	1	1