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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
Contamination /Decontamination Problem 5 5
Use of Device Problem 5 5
Defective Device 5 5
Break 4 4
Device Expiration Issue 4 4
Device Disinfection Or Sterilization Issue 4 4
Patient Device Interaction Problem 4 4
Material Discolored 4 4
Contamination 3 3
Device Reprocessing Problem 3 3
Device Operates Differently Than Expected 3 3
Particulates 3 3
Material Fragmentation 3 3
Material Deformation 3 3
Chemical Spillage 3 3
Device Rinsing Issue 3 3
Output Problem 3 3
Inadequate Instructions for Non-Healthcare Professional 2 2
Improper Chemical Reaction 2 2
Fungus in Device Environment 2 2
Gas/Air Leak 2 2
Material Integrity Problem 2 2
Device Appears to Trigger Rejection 1 1
Unexpected Therapeutic Results 1 1
Fire 1 1
Melted 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1
Difficult to Open or Close 1 1
Material Puncture/Hole 1 1
Material Erosion 1 1
Device Unsafe to Use in Environment 1 1
Loose or Intermittent Connection 1 1
Biocompatibility 1 1
Overheating of Device 1 1
Inaccurate Delivery 1 1
Labelling, Instructions for Use or Training Problem 1 1
Shelf Life Exceeded 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
No Fail-Safe Mechanism 1 1
Failure to Shut Off 1 1
Device Contamination With Biological Material 1 1
Contamination of Device Ingredient or Reagent 1 1
Leak/Splash 1 1
Failure to Clean Adequately 1 1
Unintended Collision 1 1
Fumes or Vapors 1 1
Misassembly by Users 1 1
Device Packaging Compromised 1 1
Environmental Compatibility Problem 1 1
Unexpected Shutdown 1 1
Protective Measures Problem 1 1
Device Damaged by Another Device 1 1
Failure to Disinfect 1 1
Material Too Rigid or Stiff 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 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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