TPLC - Total Product Life Cycle

show TPLC since

Device	cleanser, denture, over the counter
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	272	272
Improper or Incorrect Procedure or Method	11	11
Product Quality Problem	10	10
Patient-Device Incompatibility	9	9
Patient Device Interaction Problem	3	3
Appropriate Term/Code Not Available	3	3
Expiration Date Error	1	1
Use of Device Problem	1	1
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	161	161
No Code Available	76	76
Hypersensitivity/Allergic reaction	9	9
Foreign Body In Patient	9	9
Pain	8	8
Hemorrhage/Bleeding	6	6
Choking	6	6
Abdominal Pain	4	4
Nausea	4	4
Burning Sensation	4	4
Discomfort	4	4
Death	3	3
Inflammation	3	3
Reaction	3	3
Dementia	2	2
Cancer	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Sore Throat	2	2
Swelling/ Edema	2	2
Dyspnea	2	2
Swelling	2	2
Vomiting	2	2
Hallucination	1	1
Decreased Appetite	1	1
Ambulation Difficulties	1	1
Bronchitis	1	1
Tissue Breakdown	1	1
Loss of consciousness	1	1
Unspecified Respiratory Problem	1	1
Shock	1	1
Pneumonia	1	1
Diarrhea	1	1
Erythema	1	1
Salivary Gland Problem	1	1
Chest Pain	1	1
Numbness	1	1
Stomach Ulceration	1	1
Fever	1	1
Rash	1	1
Alteration In Body Temperature	1	1
Chemical Exposure	1	1
Cognitive Changes	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Itching Sensation	1	1
Complete Heart Block	1	1
Memory Loss/Impairment	1	1
Skin Inflammation/ Irritation	1	1
Breast Cancer	1	1
Seizures	1	1
Respiratory Distress	1	1