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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 80 80

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 316 316
Adverse Event Without Identified Device or Use Problem 285 285
Patient-Device Incompatibility 104 104
Decrease in Pressure 86 86
Appropriate Term/Code Not Available 33 33
Device Emits Odor 26 26
Defective Component 22 22
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
Output Problem 3 3
Material Deformation 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
Manufacturing, Packaging or Shipping Problem 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 269 269
Cough 165 165
Rash 157 157
Dyspnea 107 107
Headache 71 71
Skin Inflammation/ Irritation 71 71
Sore Throat 47 47
Unspecified Respiratory Problem 46 46
Pneumonia 31 31
Bronchitis 29 29
Skin Burning Sensation 27 27
Asthma 24 24
Wheezing 23 23
Chest Pain 22 22
Itching Sensation 22 22
Bacterial Infection 21 21
Sneezing 19 19
Respiratory Tract Infection 18 18
Unspecified Infection 17 17
Pain 17 17
Blister 17 17
No Clinical Signs, Symptoms or Conditions 17 17
Dizziness 16 16
Inflammation 14 14
Irritation 13 13
Insufficient Information 13 13
Skin Infection 12 12
Burning Sensation 12 12
Nausea 12 12
Reaction 12 12
No Code Available 11 11
Nasal Obstruction 9 9
Aspiration/Inhalation 9 9
Fatigue 8 8
Fever 8 8
Discomfort 8 8
Fungal Infection 7 7
No Known Impact Or Consequence To Patient 7 7
Sleep Dysfunction 6 6
Epistaxis 6 6
Dry Mouth 5 5
Eye Pain 5 5
Cancer 5 5
Swelling/ Edema 5 5
Viral Infection 5 5
Malaise 5 5
Vomiting 5 5
Skin Irritation 5 5
Erythema 5 5
Swelling 4 4
Chest Tightness/Pressure 4 4
Swollen Lymph Nodes/Glands 4 4
Localized Skin Lesion 3 3
Nodule 3 3
Respiratory Distress 3 3
Apnea 3 3
Hemorrhage/Bleeding 3 3
High Blood Pressure/ Hypertension 3 3
Hearing Impairment 2 2
Memory Loss/Impairment 2 2
Hypersensitivity/Allergic reaction 2 2
Myocardial Infarction 2 2
Eye Injury 2 2
Dry Eye(s) 2 2
Burn(s) 2 2
Vertigo 2 2
Dysphasia 2 2
Discharge 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Complaint, Ill-Defined 2 2
Contact Dermatitis 2 2
Unspecified Tissue Injury 2 2
Unspecified Eye / Vision Problem 2 2
Caustic/Chemical Burns 2 2
Lethargy 2 2
Chemical Exposure 2 2
Weight Changes 2 2
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 1 1
Balance Problems 1 1
Taste Disorder 1 1
Dysgeusia 1 1
Palpitations 1 1
Respiratory Failure 1 1
Unspecified Ear or Labyrinth Problem 1 1
Unspecified Immune System Problem 1 1
Missing Value Reason 1 1
Renal Impairment 1 1
Osteomyelitis 1 1
Alteration in Body Temperature 1 1
Drug Resistant Bacterial Infection 1 1
Ulcer 1 1
Distress 1 1
Choking 1 1
Numbness 1 1
Irritability 1 1
Sensitivity of Teeth 1 1
Diaphoresis 1 1
Excessive Tear Production 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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