Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 73 73

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 314 314
Adverse Event Without Identified Device or Use Problem 283 283
Patient-Device Incompatibility 104 104
Decrease in Pressure 86 86
Appropriate Term/Code Not Available 33 33
Device Emits Odor 26 26
Defective Component 20 20
Nonstandard Device 16 16
Pressure Problem 13 13
Product Quality Problem 9 9
Device Contamination with Chemical or Other Material 7 7
Installation-Related Problem 7 7
Patient Device Interaction Problem 4 4
Defective Device 4 4
Contamination /Decontamination Problem 4 4
Chemical Problem 3 3
Particulates 3 3
Break 3 3
Material Discolored 3 3
Material Fragmentation 3 3
Material Deformation 3 3
Output Problem 3 3
Gas/Air Leak 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Contamination 2 2
Fungus in Device Environment 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Material Puncture/Hole 1 1
Inaccurate Delivery 1 1
Fumes or Vapors 1 1
Biocompatibility 1 1
Device Damaged by Another Device 1 1
Device Unsafe to Use in Environment 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Failure to Shut Off 1 1
Material Erosion 1 1
Fire 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Device Appears to Trigger Rejection 1 1
Material Too Rigid or Stiff 1 1
Unexpected Therapeutic Results 1 1
Improper Chemical Reaction 1 1
Material Integrity Problem 1 1
No Fail-Safe Mechanism 1 1
Unexpected Shutdown 1 1
Failure to Clean Adequately 1 1
Protective Measures Problem 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 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 157 157
Dyspnea 107 107
Skin Inflammation/ Irritation 71 71
Headache 70 70
Sore Throat 46 46
Unspecified Respiratory Problem 46 46
Pneumonia 31 31
Bronchitis 29 29
Skin Burning Sensation 27 27
Wheezing 23 23
Asthma 23 23
Chest Pain 22 22
Itching Sensation 22 22
Bacterial Infection 21 21
Sneezing 19 19
Respiratory Tract Infection 17 17
Unspecified Infection 17 17
Pain 17 17
Blister 17 17
No Clinical Signs, Symptoms or Conditions 17 17
Dizziness 16 16
Inflammation 14 14
Irritation 13 13
Insufficient Information 13 13
Skin Infection 12 12
Nausea 12 12
Burning Sensation 12 12
Reaction 12 12
No Code Available 11 11
Nasal Obstruction 9 9
Aspiration/Inhalation 9 9
Fatigue 8 8
Fever 8 8
Discomfort 8 8
Fungal Infection 7 7
No Known Impact Or Consequence To Patient 7 7
Epistaxis 6 6
Sleep Dysfunction 6 6
Cancer 5 5
Eye Pain 5 5
Swelling/ Edema 5 5
Malaise 5 5
Viral Infection 5 5
Vomiting 5 5
Skin Irritation 5 5
Erythema 5 5
Swelling 4 4
Chest Tightness/Pressure 4 4
Dry Mouth 4 4
Localized Skin Lesion 3 3
Swollen Lymph Nodes/Glands 3 3
Nodule 3 3
Respiratory Distress 3 3
Apnea 3 3
Hemorrhage/Bleeding 3 3
High Blood Pressure/ Hypertension 3 3
Hypersensitivity/Allergic reaction 2 2
Myocardial Infarction 2 2
Memory Loss/Impairment 2 2
Burn(s) 2 2
Eye Injury 2 2
Dry Eye(s) 2 2
Hearing Impairment 2 2
Vertigo 2 2
Dysphasia 2 2
Discharge 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Complaint, Ill-Defined 2 2
Contact Dermatitis 2 2
Unspecified Tissue Injury 2 2
Unspecified Eye / Vision Problem 2 2
Caustic/Chemical Burns 2 2
Lethargy 2 2
Chemical Exposure 2 2
Weight Changes 2 2
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 1 1
Balance Problems 1 1
Taste Disorder 1 1
Dysgeusia 1 1
Palpitations 1 1
Respiratory Failure 1 1
Missing Value Reason 1 1
Unspecified Ear or Labyrinth Problem 1 1
Unspecified Immune System Problem 1 1
Renal Impairment 1 1
Osteomyelitis 1 1
Alteration in Body Temperature 1 1
Drug Resistant Bacterial Infection 1 1
Numbness 1 1
Ulcer 1 1
Distress 1 1
Choking 1 1
Irritability 1 1
Sensitivity of Teeth 1 1
Diaphoresis 1 1
Excessive Tear Production 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
-
-