TPLC - Total Product Life Cycle

• Device: cleanser, denture, over the counter
• Product Code: EFT
• Regulation Number: 872.3520
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	13	13
2015	20	20
2016	67	67
2017	83	83
2018	79	79
2019	55	55
2020	68	68
2021	74	74
2022	40	40
2023	44	44
2024	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	298	298
Improper or Incorrect Procedure or Method	140	140
Patient-Device Incompatibility	34	34
Insufficient Information	27	27
Use of Device Problem	20	20
Product Quality Problem	11	11
Off-Label Use	4	4
Device Operates Differently Than Expected	4	4
Human-Device Interface Problem	3	3
Inadequate User Interface	3	3
Patient Device Interaction Problem	3	3
Device Markings/Labelling Problem	2	2
Device Handling Problem	2	2
Appropriate Term/Code Not Available	2	2
Break	2	2
Material Discolored	1	1
Device Expiration Issue	1	1
Labelling, Instructions for Use or Training Problem	1	1
Loose or Intermittent Connection	1	1
Nonstandard Device	1	1
Device Emits Odor	1	1
Reaction	1	1
Naturally Worn	1	1
Device Contamination with Chemical or Other Material	1	1
Human Factors Issue	1	1
Device Ingredient or Reagent Problem	1	1
Expiration Date Error	1	1
Application Program Problem: Medication Error	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	144	144
No Code Available	128	128
Foreign Body In Patient	49	49
Pain	29	29
No Known Impact Or Consequence To Patient	26	26
Swelling	21	21
Hypersensitivity/Allergic reaction	20	20
Burning Sensation	18	18
Death	15	15
Discomfort	15	15
Complaint, Ill-Defined	14	14
Reaction	14	14
Chemical Exposure	14	14
Choking	13	13
Vomiting	13	13
Injury	11	11
Nausea	10	10
Erythema	10	10
Dyspnea	8	8
Abdominal Pain	8	8
Hemorrhage/Bleeding	7	7
Itching Sensation	7	7
Rash	6	6
Respiratory Distress	6	6
Inflammation	6	6
Cancer	6	6
Numbness	5	5
Irritation	5	5
Loss of consciousness	4	4
Dizziness	4	4
Anxiety	4	4
Sore Throat	4	4
Caustic/Chemical Burns	4	4
Ambulation Difficulties	3	3
Alteration In Body Temperature	3	3
Partial thickness (Second Degree) Burn	3	3
Confusion/ Disorientation	3	3
Aspiration/Inhalation	3	3
Edema	3	3
Diarrhea	3	3
Unspecified Infection	3	3
Overdose	3	3
Pneumonia	3	3
Loss of Vision	2	2
Weakness	2	2
Tissue Damage	2	2
Tingling	2	2
Stenosis	2	2
Ulcer	2	2
Erosion	2	2
Bradycardia	2	2
Burn(s)	2	2
Low Blood Pressure/ Hypotension	2	2
Fainting	2	2
Fatigue	2	2
Fever	2	2
Glaucoma	2	2
No Information	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Dementia	2	2
Swelling/ Edema	2	2
Patient Problem/Medical Problem	2	2
Sleep Dysfunction	2	2
Low Oxygen Saturation	2	2
Toxicity	2	2
Malaise	2	2
Depression	1	1
Disability	1	1
No Consequences Or Impact To Patient	1	1
Anaphylactoid	1	1
Fungal Infection	1	1
Respiratory Tract Infection	1	1
Obstruction/Occlusion	1	1
Skin Inflammation	1	1
Chest Tightness/Pressure	1	1
Collapse	1	1
Coma	1	1
Skin Tears	1	1
Cognitive Changes	1	1
Dysuria	1	1
Blood Loss	1	1
Complete Heart Block	1	1
Tissue Breakdown	1	1
Hallucination	1	1
Salivary Gland Problem	1	1
Dry Mouth	1	1
Stomach Ulceration	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Skin Inflammation/ Irritation	1	1
Decreased Appetite	1	1
Test Result	1	1
Device Embedded In Tissue or Plaque	1	1
Headache	1	1
Hemoptysis	1	1
Foreign Body Sensation in Eye	1	1
Asphyxia	1	1
Fall	1	1
Hypoxia	1	1
Ischemia	1	1
Abnormal Blood Gases	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Family Dollar Stores, Llc.	II	Nov-07-2023
2	Family Dollar Stores, Llc.	II	Aug-17-2022