TPLC - Total Product Life Cycle

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Device	disinfectant, medical devices
Regulation Description	General purpose disinfectants.
Product Code	LRJ
Regulation Number	880.6890
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	360	360
Adverse Event Without Identified Device or Use Problem	309	313
Patient-Device Incompatibility	113	121
Decrease in Pressure	90	90
Defective Component	37	38
Appropriate Term/Code Not Available	33	33
Device Emits Odor	30	33
Nonstandard Device	29	45
Pressure Problem	15	15
Patient Device Interaction Problem	10	10
Product Quality Problem	9	9
Installation-Related Problem	7	7
Device Contamination with Chemical or Other Material	7	8
Output Problem	7	8
Defective Device	6	6
Particulates	5	7
Contamination /Decontamination Problem	5	5
Use of Device Problem	4	4
Material Discolored	4	5
Material Fragmentation	4	10
Contamination	4	4
Chemical Problem	3	3
Fungus in Device Environment	3	3
Break	3	3
Material Deformation	3	3
Improper or Incorrect Procedure or Method	2	2
Gas/Air Leak	2	3
Restricted Flow rate	2	2
Unexpected Shutdown	2	3
Inadequate Instructions for Non-Healthcare Professional	2	2
Device-Device Incompatibility	2	2
Leak/Splash	2	3
Microbial Contamination of Device	1	1
Failure to Clean Adequately	1	1
Air/Gas in Device	1	1
No Fail-Safe Mechanism	1	1
Degraded	1	1
No Pressure	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Smoking	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	2
Material Puncture/Hole	1	1
Material Erosion	1	2
Device Damaged by Another Device	1	1
Device Unsafe to Use in Environment	1	1
Environmental Compatibility Problem	1	1
Misassembly by Users	1	1
Fire	1	1
Device Ingredient or Reagent Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	282	285
Cough	207	214
Rash	174	175
Dyspnea	121	124
Headache	83	87
Skin Inflammation/ Irritation	81	82
Unspecified Respiratory Problem	58	64
Sore Throat	49	53
Pneumonia	39	42
Bronchitis	34	36
Skin Burning Sensation	29	30
No Clinical Signs, Symptoms or Conditions	28	31
Asthma	27	28
Bacterial Infection	24	26
Wheezing	24	25
Respiratory Tract Infection	24	24
Chest Pain	23	24
Itching Sensation	22	24
Sneezing	21	22
Unspecified Infection	20	21
Dizziness	17	18
Blister	17	17
Insufficient Information	17	21
Nausea	16	17
Pain	16	18
Inflammation	14	15
Aspiration/Inhalation	13	19
Burning Sensation	13	15
Skin Infection	13	13
Irritation	12	12
Reaction	11	11
Fatigue	9	9
Nasal Obstruction	9	9
Sleep Dysfunction	9	10
No Code Available	9	9
Swelling/ Edema	8	9
Fever	8	11
Hypersensitivity/Allergic reaction	8	8
Discomfort	8	8
Viral Infection	8	8
Fungal Infection	7	7
Nodule	6	6
Epistaxis	6	6
Eye Pain	6	6
No Known Impact Or Consequence To Patient	6	6
Dry Mouth	5	5
Malaise	5	5
Vomiting	5	5
Erythema	5	5
Apnea	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-22-2024
2	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-02-2022
3	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-01-2022
4	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
5	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022