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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
2014 18 18
2015 15 15
2016 13 13
2017 6 6
2018 15 15
2019 12 12
2020 73 73
2021 473 473
2022 171 171
2023 95 95
2024 73 73

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 324 324
Adverse Event Without Identified Device or Use Problem 288 288
Patient-Device Incompatibility 113 113
Decrease in Pressure 86 86
Appropriate Term/Code Not Available 37 37
Device Emits Odor 28 28
Defective Component 20 20
Nonstandard Device 16 16
Pressure Problem 13 13
Product Quality Problem 11 11
Improper or Incorrect Procedure or Method 8 8
Device Contamination with Chemical or Other Material 8 8
Installation-Related Problem 7 7
Chemical Problem 6 6
Use of Device Problem 5 5
Contamination /Decontamination Problem 5 5
Defective Device 5 5
Patient Device Interaction Problem 4 4
Device Disinfection Or Sterilization Issue 4 4
Device Expiration Issue 4 4
Break 4 4
Material Discolored 4 4
Device Reprocessing Problem 3 3
Contamination 3 3
Material Fragmentation 3 3
Particulates 3 3
Chemical Spillage 3 3
Device Rinsing Issue 3 3
Device Operates Differently Than Expected 3 3
Output Problem 3 3
Material Deformation 3 3
Material Integrity Problem 2 2
Gas/Air Leak 2 2
Improper Chemical Reaction 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Fungus in Device Environment 2 2
Inaccurate Delivery 1 1
Fumes or Vapors 1 1
Biocompatibility 1 1
Material Puncture/Hole 1 1
Device Appears to Trigger Rejection 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Shelf Life Exceeded 1 1
Unexpected Therapeutic Results 1 1
Fire 1 1
Unintended Collision 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Failure to Disinfect 1 1
Material Erosion 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination With Biological Material 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Device Unsafe to Use in Environment 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Failure to Shut Off 1 1
No Fail-Safe Mechanism 1 1
Protective Measures Problem 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Unexpected Shutdown 1 1
Failure to Clean Adequately 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 268 268
Cough 163 163
Rash 161 161
Dyspnea 111 111
Headache 73 73
Skin Inflammation/ Irritation 71 71
Unspecified Respiratory Problem 46 46
Sore Throat 46 46
Pneumonia 32 32
Bronchitis 29 29
Asthma 28 28
Itching Sensation 27 27
Skin Burning Sensation 27 27
Wheezing 23 23
Reaction 23 23
Chest Pain 23 23
No Known Impact Or Consequence To Patient 22 22
Bacterial Infection 21 21
Burning Sensation 21 21
Pain 20 20
Sneezing 20 20
Unspecified Infection 17 17
Respiratory Tract Infection 17 17
Blister 17 17
No Clinical Signs, Symptoms or Conditions 17 17
Irritation 16 16
Dizziness 16 16
Inflammation 15 15
No Code Available 15 15
Insufficient Information 13 13
Nausea 13 13
Skin Infection 12 12
Discomfort 11 11
Fever 11 11
Fatigue 9 9
Erythema 9 9
Aspiration/Inhalation 9 9
Chemical Exposure 9 9
Nasal Obstruction 9 9
Fungal Infection 8 8
Swelling 8 8
Skin Irritation 7 7
Hypersensitivity/Allergic reaction 7 7
Vomiting 6 6
Sleep Dysfunction 6 6
Caustic/Chemical Burns 6 6
Epistaxis 6 6
Eye Pain 5 5
Swelling/ Edema 5 5
Viral Infection 5 5
Malaise 5 5
Cancer 5 5
Respiratory Distress 5 5
Chest Tightness/Pressure 4 4
Dry Mouth 4 4
Localized Skin Lesion 3 3
Nodule 3 3
Swollen Lymph Nodes/Glands 3 3
High Blood Pressure/ Hypertension 3 3
Hemorrhage/Bleeding 3 3
Apnea 3 3
Burn(s) 3 3
Eye Injury 3 3
Dry Eye(s) 2 2
Hearing Impairment 2 2
Myocardial Infarction 2 2
Memory Loss/Impairment 2 2
Red Eye(s) 2 2
Skin Discoloration 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Complaint, Ill-Defined 2 2
Ulcer 2 2
Dysphasia 2 2
Vertigo 2 2
Blurred Vision 2 2
Discharge 2 2
No Information 2 2
Weight Changes 2 2
No Patient Involvement 2 2
Choking 2 2
Lethargy 2 2
Contact Dermatitis 2 2
Unspecified Eye / Vision Problem 2 2
Unspecified Tissue Injury 2 2
Alteration in Body Temperature 1 1
Unspecified Ear or Labyrinth Problem 1 1
Renal Impairment 1 1
Osteomyelitis 1 1
Drug Resistant Bacterial Infection 1 1
Burn, Thermal 1 1
Palpitations 1 1
Respiratory Failure 1 1
Numbness 1 1
Irritability 1 1
Sensitivity of Teeth 1 1
Skin Inflammation 1 1
Diaphoresis 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 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
6 Medtrol, Inc. II Jun-22-2010
7 Metrex Research, LLC. II Mar-03-2017
8 Metrex Research, LLC. II Aug-24-2012
9 Wexford Labs Inc II Nov-19-2013
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