TPLC - Total Product Life Cycle

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Device	heat source for bleaching teeth
Product Code	EEG
Regulation Number	872.6475
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	30	30
Improper or Incorrect Procedure or Method	7	7
Patient-Device Incompatibility	6	6
Insufficient Information	3	3
Patient Device Interaction Problem	2	2
Unintended Electrical Shock	2	2
Appropriate Term/Code Not Available	1	1
Improper Chemical Reaction	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Off-Label Use	1	1
Product Quality Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Smoking	1	1
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Sensitivity of Teeth	12	12
Swelling	7	7
Reaction	7	7
Patient Problem/Medical Problem	7	7
Pain	6	6
Burn(s)	6	6
Tooth Fracture	3	3
Burning Sensation	3	3
No Clinical Signs, Symptoms or Conditions	3	3
Caustic/Chemical Burns	2	2
Hypersensitivity/Allergic reaction	2	2
Nausea	1	1
Erythema	1	1
Headache	1	1
Red Eye(s)	1	1
Increased Sensitivity	1	1
Tissue Damage	1	1
Vomiting	1	1
Dysphasia	1	1
Ulcer	1	1
Discomfort	1	1
Complaint, Ill-Defined	1	1
Sleep Dysfunction	1	1
Burn, Thermal	1	1
Electric Shock	1	1
Vaso-Vagal Response	1	1
Numbness	1	1
Partial thickness (Second Degree) Burn	1	1
Full thickness (Third Degree) Burn	1	1
No Code Available	1	1
Unspecified Respiratory Problem	1	1
Blister	1	1
Swelling/ Edema	1	1
Arrhythmia	1	1