TPLC - Total Product Life Cycle

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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	316	316
Improper or Incorrect Procedure or Method	140	140
Patient-Device Incompatibility	35	35
Insufficient Information	27	27
Use of Device Problem	20	20
Product Quality Problem	11	11
Device Operates Differently Than Expected	4	4
Off-Label Use	4	4
Patient Device Interaction Problem	3	3
Appropriate Term/Code Not Available	3	3
Human-Device Interface Problem	3	3
Inadequate User Interface	3	3
Break	2	2
Device Markings/Labelling Problem	2	2
Device Handling Problem	2	2
Device Ingredient or Reagent Problem	1	1
Reaction	1	1
Expiration Date Error	1	1
Device Expiration Issue	1	1
Human Factors Issue	1	1
Nonstandard Device	1	1
Naturally Worn	1	1
Loose or Intermittent Connection	1	1
Application Program Problem: Medication Error	1	1
Material Discolored	1	1
Device Contamination with Chemical or Other Material	1	1
Device Emits Odor	1	1
Labelling, Instructions for Use or Training Problem	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	128	128
Foreign Body In Patient	50	50
Pain	32	32
No Known Impact Or Consequence To Patient	26	26
Swelling	21	21
Hypersensitivity/Allergic reaction	21	21
Burning Sensation	19	19
Discomfort	16	16
Death	15	15
Vomiting	14	14
Reaction	14	14
Complaint, Ill-Defined	14	14
Chemical Exposure	14	14
Choking	13	13
Injury	11	11
Erythema	10	10
Nausea	10	10
Abdominal Pain	9	9
Dyspnea	8	8
Hemorrhage/Bleeding	7	7
Inflammation	7	7
Itching Sensation	7	7
Respiratory Distress	6	6
Cancer	6	6
Rash	6	6
Numbness	5	5
Irritation	5	5
Loss of consciousness	4	4
Sore Throat	4	4
Diarrhea	4	4
Dizziness	4	4
Anxiety	4	4
Caustic/Chemical Burns	4	4
Unspecified Infection	3	3
Pneumonia	3	3
Ambulation Difficulties	3	3
Alteration In Body Temperature	3	3
Confusion/ Disorientation	3	3
Overdose	3	3
Edema	3	3
Partial thickness (Second Degree) Burn	3	3
Aspiration/Inhalation	3	3
Fatigue	2	2
Low Blood Pressure/ Hypotension	2	2
Bradycardia	2	2
Low Oxygen Saturation	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Sleep Dysfunction	2	2
Patient Problem/Medical Problem	2	2