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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device disinfectant, medical devices
Product CodeLRJ
Regulation Number 880.6890
Device Class 1

MDR Year MDR Reports MDR Events
2019 12 12
2020 73 73
2021 473 473
2022 171 171
2023 95 95
2024 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 308 308
Adverse Event Without Identified Device or Use Problem 281 281
Patient-Device Incompatibility 104 104
Decrease in Pressure 86 86
Appropriate Term/Code Not Available 33 33
Device Emits Odor 26 26
Defective Component 17 17
Nonstandard Device 16 16
Pressure Problem 13 13
Product Quality Problem 9 9
Device Contamination with Chemical or Other Material 7 7
Installation-Related Problem 7 7
Patient Device Interaction Problem 4 4
Defective Device 4 4
Contamination /Decontamination Problem 4 4
Chemical Problem 3 3
Particulates 3 3
Break 3 3
Material Discolored 3 3
Material Fragmentation 3 3
Material Deformation 3 3
Output Problem 3 3
Gas/Air Leak 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Contamination 2 2
Fungus in Device Environment 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Material Puncture/Hole 1 1
Inaccurate Delivery 1 1
Fumes or Vapors 1 1
Biocompatibility 1 1
Device Damaged by Another Device 1 1
Device Unsafe to Use in Environment 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Failure to Shut Off 1 1
Material Erosion 1 1
Fire 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Device Appears to Trigger Rejection 1 1
Material Too Rigid or Stiff 1 1
Unexpected Therapeutic Results 1 1
Improper Chemical Reaction 1 1
Material Integrity Problem 1 1
No Fail-Safe Mechanism 1 1
Unexpected Shutdown 1 1
Failure to Clean Adequately 1 1
Protective Measures Problem 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 267 267
Cough 162 162
Rash 153 153
Dyspnea 107 107
Skin Inflammation/ Irritation 70 70
Headache 67 67
Sore Throat 46 46
Unspecified Respiratory Problem 44 44
Pneumonia 29 29
Bronchitis 29 29
Skin Burning Sensation 27 27
Wheezing 23 23
Asthma 22 22
Chest Pain 22 22
Itching Sensation 22 22
Bacterial Infection 21 21
Sneezing 19 19
Respiratory Tract Infection 17 17
Unspecified Infection 17 17
Pain 17 17
Blister 17 17
Dizziness 16 16
Inflammation 14 14
No Clinical Signs, Symptoms or Conditions 14 14
Insufficient Information 13 13
Irritation 13 13
Nausea 12 12
Reaction 12 12
Skin Infection 12 12
No Code Available 11 11
Burning Sensation 10 10
Nasal Obstruction 9 9
Discomfort 8 8
Fatigue 8 8
Fever 8 8
Aspiration/Inhalation 8 8
Fungal Infection 7 7
No Known Impact Or Consequence To Patient 7 7
Sleep Dysfunction 6 6
Epistaxis 6 6
Eye Pain 5 5
Cancer 5 5
Swelling/ Edema 5 5
Erythema 5 5
Viral Infection 5 5
Vomiting 5 5
Skin Irritation 5 5
Swelling 4 4
Malaise 4 4
Chest Tightness/Pressure 4 4
Dry Mouth 4 4
Localized Skin Lesion 3 3
Swollen Lymph Nodes/Glands 3 3
Nodule 3 3
Respiratory Distress 3 3
Apnea 3 3
Hemorrhage/Bleeding 3 3
High Blood Pressure/ Hypertension 3 3
Hypersensitivity/Allergic reaction 2 2
Myocardial Infarction 2 2
Memory Loss/Impairment 2 2
Burn(s) 2 2
Eye Injury 2 2
Dry Eye(s) 2 2
Hearing Impairment 2 2
Vertigo 2 2
Dysphasia 2 2
Discharge 2 2
Complaint, Ill-Defined 2 2
Unspecified Tissue Injury 2 2
Unspecified Eye / Vision Problem 2 2
Contact Dermatitis 2 2
Caustic/Chemical Burns 2 2
Lethargy 2 2
Weight Changes 2 2
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 1 1
Chemical Exposure 1 1
Balance Problems 1 1
Taste Disorder 1 1
Dysgeusia 1 1
Missing Value Reason 1 1
Renal Impairment 1 1
Osteomyelitis 1 1
Unspecified Ear or Labyrinth Problem 1 1
Unspecified Immune System Problem 1 1
Alteration in Body Temperature 1 1
Drug Resistant Bacterial Infection 1 1
Ulcer 1 1
Numbness 1 1
Choking 1 1
Palpitations 1 1
Respiratory Failure 1 1
Irritability 1 1
Sensitivity of Teeth 1 1
Diaphoresis 1 1
Excessive Tear Production 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Headache, Lumbar Puncture 1 1

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
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