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

MDR Year MDR Reports MDR Events
2017 6 6
2018 15 15
2019 12 12
2020 73 73
2021 473 473

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 210 210
Insufficient Information 186 186
Patient-Device Incompatibility 95 95
Decrease in Pressure 48 48
Device Emits Odor 24 24
Product Quality Problem 11 11
Appropriate Term/Code Not Available 9 9
Nonstandard Device 7 7
Installation-Related Problem 6 6
Device Contamination with Chemical or Other Material 5 5
Contamination /Decontamination Problem 5 5
Break 4 4
Material Discolored 3 3
Chemical Problem 3 3
Defective Device 3 3
Gas Leak 2 2
Device Reprocessing Problem 2 2
Contamination 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 2 2
Fungus in Device Environment 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Patient Device Interaction Problem 2 2
Output Problem 2 2
Pressure Problem 1 1
Protective Measures Problem 1 1
No Apparent Adverse Event 1 1
Unexpected Shutdown 1 1
Failure to Clean Adequately 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Inaccurate Delivery 1 1
Fumes or Vapors 1 1
Device Appears to Trigger Rejection 1 1
Material Too Rigid or Stiff 1 1
Shelf Life Exceeded 1 1
Unexpected Therapeutic Results 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Failure to Disinfect 1 1
Material Erosion 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Improper Chemical Reaction 1 1
Chemical Spillage 1 1
Biocompatibility 1 1
Device Contamination With Biological Material 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Operates Differently Than Expected 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
Environmental Compatibility Problem 1 1
Failure to Shut Off 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 184 184
Rash 108 108
Cough 76 76
Dyspnea 72 72
Skin Inflammation/ Irritation 53 53
Headache 45 45
Sore Throat 31 31
Unspecified Respiratory Problem 19 19
Asthma 17 17
Itching Sensation 17 17
Pain 16 16
Skin Burning Sensation 16 16
Pneumonia 15 15
Chest Pain 15 15
Bacterial Infection 14 14
Bronchitis 13 13
Irritation 13 13
Unspecified Infection 13 13
Reaction 12 12
Dizziness 12 12
No Known Impact Or Consequence To Patient 12 12
No Code Available 11 11
Respiratory Tract Infection 11 11
Sneezing 10 10
Inflammation 10 10
Nausea 10 10
Wheezing 9 9
Fatigue 7 7
Burning Sensation 7 7
Nasal Obstruction 7 7
Swelling 6 6
Discomfort 6 6
Insufficient Information 6 6
Skin Infection 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Skin Irritation 5 5
Erythema 5 5
Respiratory Distress 5 5
Fever 4 4
Vomiting 4 4
Chest Tightness/Pressure 4 4
Fungal Infection 4 4
Sleep Dysfunction 4 4
Blister 4 4
Dry Mouth 4 4
Eye Pain 3 3
Epistaxis 3 3
Swelling/ Edema 3 3
Caustic/Chemical Burns 3 3
Viral Infection 3 3
Eye Injury 3 3
Hemorrhage/Bleeding 2 2
High Blood Pressure/ Hypertension 2 2
Memory Loss/Impairment 2 2
Chemical Exposure 2 2
Weight Changes 2 2
Blurred Vision 2 2
Complaint, Ill-Defined 2 2
Malaise 2 2
Ulcer 2 2
Discharge 2 2
Unspecified Tissue Injury 2 2
No Information 2 2
Unspecified Eye / Vision Problem 2 2
Swollen Lymph Nodes/Glands 2 2
Renal Impairment 1 1
Osteomyelitis 1 1
Unspecified Ear or Labyrinth Problem 1 1
Missing Value Reason 1 1
Cancer 1 1
Dysgeusia 1 1
Excessive Tear Production 1 1
Numbness 1 1
Visual Disturbances 1 1
Headache, Lumbar Puncture 1 1
Chills 1 1
HIV, Human Immunodeficiency Virus 1 1
No Patient Involvement 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 1 1
Irritability 1 1
Sensitivity of Teeth 1 1
Choking 1 1
Palpitations 1 1
Myocardial Infarction 1 1
Hyperglycemia 1 1
Skin Discoloration 1 1
Red Eye(s) 1 1
Peeling 1 1
Dry Eye(s) 1 1
Hair Loss 1 1
Hearing Impairment 1 1
Hemoptysis 1 1
Burn(s) 1 1
Cellulitis 1 1
Autoimmune Reaction 1 1
Syncope 1 1
Apnea 1 1
Aspiration/Inhalation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Metrex Research, LLC. II Mar-03-2017
-
-