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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
Regulation Description General purpose disinfectants.
Product CodeLRJ
Regulation Number 880.6890
Device Class 1

MDR Year MDR Reports MDR Events
2021 497 508
2022 171 192
2023 95 97
2024 116 116
2025 70 70
2026 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Device Problem Information 359 359
Adverse Event Without Identified Device or Use Problem 265 265
Decrease in Pressure 92 92
Patient-Device Incompatibility 51 51
Defective Component 36 36
Appropriate Device Problem Term/Code Not Available 33 33
Pressure Problem 17 17
Installation-Related Problem 7 7
Restricted Flow rate 4 4
Unsealed Device Packaging 1 1
Defective Device 1 1
Use of Device Problem 1 1
No Pressure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Overheating of Device 1 1
Leak/Splash 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 279 282
Cough 202 209
Rash 169 170
Dyspnea 105 107
Skin Inflammation/ Irritation 82 83
Headache 77 81
Unspecified Respiratory Problem 59 65
Sinusitis 57 57
Sore Throat 48 52
Pneumonia 38 40
Bronchitis 31 33
Skin Burning Sensation 29 30
No Clinical Signs, Symptoms or Conditions 28 31
Bacterial Infection 25 27
Wheezing 23 24
Respiratory Tract Infection 23 23
Itching Sensation 22 24
Asthma 22 23
Chest Pain 21 22
Sneezing 20 20
Blister 17 17
Insufficient Information 17 21
Unspecified Infection 17 18
Nausea 16 17
Dizziness 15 16
Aspiration/Inhalation 13 19
Skin Infection 13 13
Inflammation 12 13
Hypersensitivity/Allergic reaction 10 10
Burning Sensation 9 11
Pain 9 11
Nasal Obstruction 8 8
Swelling/ Edema 8 9
Fever 8 11
Viral Infection 8 8
Fatigue 7 7
Fungal Infection 7 7
Eye Pain 6 6
Epistaxis 6 6
Sleep Dysfunction 6 6
Nodule 6 6
Dry Mouth 5 5
Vomiting 5 5
Malaise 4 4
Cancer 4 6
Swollen Lymph Nodes/Glands 4 5
Reaction 4 4
Unspecified Eye / Vision Problem 4 4
Apnea 3 3
Localized Skin Lesion 3 3

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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