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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 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 312 312
Adverse Event Without Identified Device or Use Problem 285 285
Patient-Device Incompatibility 113 113
Decrease in Pressure 86 86
Appropriate Term/Code Not Available 37 37
Device Emits Odor 28 28
Nonstandard Device 16 16
Defective Component 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 266 266
Cough 160 160
Rash 156 156
Dyspnea 109 109
Skin Inflammation/ Irritation 70 70
Headache 69 69
Sore Throat 46 46
Unspecified Respiratory Problem 43 43
Pneumonia 30 30
Bronchitis 29 29
Asthma 27 27
Itching Sensation 27 27
Skin Burning Sensation 26 26
Wheezing 23 23
Chest Pain 23 23
Reaction 23 23
No Known Impact Or Consequence To Patient 22 22
Sneezing 20 20
Pain 20 20
Bacterial Infection 20 20
Burning Sensation 19 19
Unspecified Infection 17 17
Respiratory Tract Infection 17 17
Blister 16 16
Irritation 16 16
Dizziness 16 16
Inflammation 15 15
No Code Available 15 15
No Clinical Signs, Symptoms or Conditions 14 14
Insufficient Information 13 13
Nausea 13 13
Discomfort 11 11
Fever 11 11
Skin Infection 11 11
Nasal Obstruction 9 9
Fatigue 9 9
Erythema 9 9
Aspiration/Inhalation 8 8
Swelling 8 8
Chemical Exposure 8 8
Fungal Infection 8 8
Skin Irritation 7 7
Hypersensitivity/Allergic reaction 7 7
Vomiting 6 6
Sleep Dysfunction 6 6
Epistaxis 6 6
Caustic/Chemical Burns 6 6
Cancer 5 5
Eye Pain 5 5
Swelling/ Edema 5 5
Viral Infection 5 5
Respiratory Distress 5 5
Dry Mouth 4 4
Chest Tightness/Pressure 4 4
Malaise 3 3
Swollen Lymph Nodes/Glands 3 3
Localized Skin Lesion 3 3
Nodule 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
Ulcer 2 2
Complaint, Ill-Defined 2 2
Dysphasia 2 2
Vertigo 2 2
Blurred Vision 2 2
Discharge 2 2
Unspecified Tissue Injury 2 2
Contact Dermatitis 2 2
Unspecified Eye / Vision Problem 2 2
No Information 2 2
Lethargy 2 2
Choking 2 2
Weight Changes 2 2
No Patient Involvement 2 2
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 1 1
Burn, Thermal 1 1
Palpitations 1 1
Respiratory Failure 1 1
Irritability 1 1
Sensitivity of Teeth 1 1
Skin Inflammation 1 1
Diaphoresis 1 1
Partial thickness (Second Degree) Burn 1 1
Balance Problems 1 1
Taste Disorder 1 1
Dysgeusia 1 1
Unspecified Immune System Problem 1 1
Missing Value Reason 1 1
Unspecified Ear or Labyrinth Problem 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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