TPLC - Total Product Life Cycle

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Device	disinfectant, medical devices
Product Code	LRJ
Regulation Number	880.6890
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	322	322
Adverse Event Without Identified Device or Use Problem	288	288
Patient-Device Incompatibility	104	104
Decrease in Pressure	86	86
Appropriate Term/Code Not Available	33	33
Device Emits Odor	26	26
Defective Component	24	24
Nonstandard Device	16	16
Pressure Problem	13	13
Product Quality Problem	9	9
Installation-Related Problem	7	7
Device Contamination with Chemical or Other Material	7	7
Contamination /Decontamination Problem	4	4
Patient Device Interaction Problem	4	4
Defective Device	4	4
Material Deformation	3	3
Chemical Problem	3	3
Material Fragmentation	3	3
Output Problem	3	3
Material Discolored	3	3
Break	3	3
Particulates	3	3
Gas/Air Leak	2	2
Fungus in Device Environment	2	2
Improper or Incorrect Procedure or Method	2	2
Inadequate Instructions for Non-Healthcare Professional	2	2
Contamination	2	2
Use of Device Problem	2	2
Protective Measures Problem	1	1
Material Erosion	1	1
Unexpected Therapeutic Results	1	1
No Fail-Safe Mechanism	1	1
Device Damaged by Another Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Failure to Shut Off	1	1
Material Too Rigid or Stiff	1	1
Device Unsafe to Use in Environment	1	1
Device Appears to Trigger Rejection	1	1
Labelling, Instructions for Use or Training Problem	1	1
Unsealed Device Packaging	1	1
Biocompatibility	1	1
Leak/Splash	1	1
Material Puncture/Hole	1	1
Fumes or Vapors	1	1
Improper Chemical Reaction	1	1
Failure to Clean Adequately	1	1
No Apparent Adverse Event	1	1
Misassembly by Users	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	272	272
Cough	167	167
Rash	159	159
Dyspnea	109	109
Skin Inflammation/ Irritation	72	72
Headache	71	71
Unspecified Respiratory Problem	47	47
Sore Throat	47	47
Bronchitis	31	31
Pneumonia	31	31
Skin Burning Sensation	27	27
Asthma	24	24
Wheezing	23	23
Itching Sensation	22	22
Chest Pain	22	22
Bacterial Infection	21	21
Sneezing	19	19
Respiratory Tract Infection	19	19
No Clinical Signs, Symptoms or Conditions	18	18
Pain	17	17
Unspecified Infection	17	17
Blister	17	17
Dizziness	16	16
Inflammation	14	14
Insufficient Information	13	13
Nausea	13	13
Irritation	13	13
Reaction	12	12
Skin Infection	12	12
Burning Sensation	12	12
No Code Available	11	11
Aspiration/Inhalation	10	10
Nasal Obstruction	9	9
Fever	8	8
Discomfort	8	8
Fatigue	8	8
No Known Impact Or Consequence To Patient	7	7
Sleep Dysfunction	7	7
Fungal Infection	7	7
Epistaxis	6	6
Eye Pain	5	5
Swelling/ Edema	5	5
Skin Irritation	5	5
Malaise	5	5
Dry Mouth	5	5
Viral Infection	5	5
Cancer	5	5
Vomiting	5	5
Erythema	5	5
Swelling	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