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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 110 110

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 329 329
Adverse Event Without Identified Device or Use Problem 294 294
Patient-Device Incompatibility 104 104
Decrease in Pressure 86 86
Appropriate Term/Code Not Available 33 33
Defective Component 29 29
Device Emits Odor 26 26
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
Defective Device 4 4
Contamination /Decontamination Problem 4 4
Patient Device Interaction Problem 4 4
Chemical Problem 3 3
Break 3 3
Output Problem 3 3
Material Fragmentation 3 3
Material Discolored 3 3
Particulates 3 3
Material Deformation 3 3
Inadequate Instructions for Non-Healthcare Professional 2 2
Improper or Incorrect Procedure or Method 2 2
Fungus in Device Environment 2 2
Contamination 2 2
Use of Device Problem 2 2
Gas/Air Leak 2 2
Biocompatibility 1 1
Loose or Intermittent Connection 1 1
Improper Chemical Reaction 1 1
Overheating of Device 1 1
Unexpected Therapeutic Results 1 1
Device Appears to Trigger Rejection 1 1
Melted 1 1
Protective Measures Problem 1 1
Device Dislodged or Dislocated 1 1
Inaccurate Delivery 1 1
No Apparent Adverse Event 1 1
Labelling, Instructions for Use or Training Problem 1 1
Misassembly by Users 1 1
Environmental Compatibility Problem 1 1
Device Unsafe to Use in Environment 1 1
Device Damaged by Another Device 1 1
Material Too Rigid or Stiff 1 1
Failure to Clean Adequately 1 1
No Fail-Safe Mechanism 1 1
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 275 275
Cough 174 174
Rash 162 162
Dyspnea 112 112
Skin Inflammation/ Irritation 74 74
Headache 73 73
Unspecified Respiratory Problem 48 48
Sore Throat 47 47
Pneumonia 32 32
Bronchitis 31 31
Skin Burning Sensation 28 28
Asthma 24 24
Itching Sensation 23 23
Wheezing 23 23
Chest Pain 22 22
Bacterial Infection 21 21
Sneezing 20 20
Respiratory Tract Infection 19 19
No Clinical Signs, Symptoms or Conditions 19 19
Unspecified Infection 17 17
Pain 17 17
Blister 17 17
Dizziness 16 16
Insufficient Information 14 14
Inflammation 14 14
Irritation 13 13
Nausea 13 13
Skin Infection 12 12
Reaction 12 12
Burning Sensation 12 12
No Code Available 11 11
Aspiration/Inhalation 10 10
Nasal Obstruction 9 9
Discomfort 8 8
Fever 8 8
Fatigue 8 8
Fungal Infection 7 7
Sleep Dysfunction 7 7
No Known Impact Or Consequence To Patient 7 7
Eye Pain 6 6
Epistaxis 6 6
Viral Infection 5 5
Vomiting 5 5
Erythema 5 5
Dry Mouth 5 5
Swelling/ Edema 5 5
Cancer 5 5
Malaise 5 5
Skin Irritation 5 5
Nodule 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
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