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

MDR Year MDR Reports MDR Events
2020 73 75
2021 497 508
2022 171 192
2023 95 97
2024 116 116
2025 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 357 357
Adverse Event Without Identified Device or Use Problem 307 311
Patient-Device Incompatibility 113 121
Decrease in Pressure 90 90
Defective Component 36 37
Appropriate Term/Code Not Available 33 33
Device Emits Odor 30 33
Nonstandard Device 29 45
Pressure Problem 15 15
Product Quality Problem 9 9
Installation-Related Problem 7 7
Device Contamination with Chemical or Other Material 7 8
Defective Device 6 6
Particulates 5 7
Patient Device Interaction Problem 5 5
Contamination /Decontamination Problem 5 5
Output Problem 4 5
Material Discolored 4 5
Material Fragmentation 4 10
Contamination 4 4
Fungus in Device Environment 3 3
Material Deformation 3 3
Use of Device Problem 3 3
Chemical Problem 3 3
Break 3 3
Improper or Incorrect Procedure or Method 2 2
Leak/Splash 2 3
Gas/Air Leak 2 3
Restricted Flow rate 2 2
Device-Device Incompatibility 2 2
Unexpected Shutdown 2 3
Inadequate Instructions for Non-Healthcare Professional 2 2
Noise, Audible 1 1
Biocompatibility 1 1
Loose or Intermittent Connection 1 2
Improper Chemical Reaction 1 1
Overheating of Device 1 1
Unexpected Therapeutic Results 1 1
Device Appears to Trigger Rejection 1 1
Melted 1 1
Protective Measures Problem 1 1
Device Dislodged or Dislocated 1 1
Inaccurate Delivery 1 3
Activation Failure 1 1
Material Separation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Failure to Shut Off 1 2
Fumes or Vapors 1 1
Misassembly by Users 1 1
Environmental Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 281 284
Cough 204 211
Rash 171 172
Dyspnea 121 124
Headache 82 86
Skin Inflammation/ Irritation 79 80
Unspecified Respiratory Problem 56 62
Sore Throat 49 53
Pneumonia 39 42
Bronchitis 34 36
Skin Burning Sensation 29 30
Asthma 27 28
No Clinical Signs, Symptoms or Conditions 27 30
Respiratory Tract Infection 24 24
Bacterial Infection 24 26
Wheezing 24 25
Chest Pain 23 24
Itching Sensation 22 24
Sneezing 21 22
Unspecified Infection 20 21
Insufficient Information 17 21
Blister 17 17
Dizziness 17 18
Pain 16 18
Nausea 16 17
Inflammation 14 15
Burning Sensation 13 15
Aspiration/Inhalation 13 19
Skin Infection 13 13
Irritation 12 12
Reaction 11 11
Fatigue 9 9
Sleep Dysfunction 9 10
No Code Available 9 9
Nasal Obstruction 9 9
Discomfort 8 8
Fever 8 11
Viral Infection 8 8
Swelling/ Edema 8 9
Fungal Infection 7 7
Eye Pain 6 6
Nodule 6 6
Epistaxis 6 6
No Known Impact Or Consequence To Patient 6 6
Erythema 5 5
Vomiting 5 5
Dry Mouth 5 5
Malaise 5 5
Cancer 4 6
Apnea 4 4

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
-
-