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TPLC
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Device
disinfectant, medical devices
Product Code
LRJ
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
34
34
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
297
297
Adverse Event Without Identified Device or Use Problem
277
277
Patient-Device Incompatibility
104
104
Decrease in Pressure
86
86
Appropriate Term/Code Not Available
33
33
Device Emits Odor
26
26
Nonstandard Device
16
16
Defective Component
13
13
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
261
261
Cough
157
157
Rash
148
148
Dyspnea
105
105
Skin Inflammation/ Irritation
70
70
Headache
64
64
Sore Throat
46
46
Unspecified Respiratory Problem
42
42
Pneumonia
29
29
Bronchitis
28
28
Skin Burning Sensation
25
25
Wheezing
23
23
Asthma
22
22
Chest Pain
22
22
Itching Sensation
22
22
Bacterial Infection
20
20
Sneezing
19
19
Respiratory Tract Infection
17
17
Unspecified Infection
17
17
Pain
17
17
Dizziness
16
16
Blister
16
16
No Clinical Signs, Symptoms or Conditions
14
14
Insufficient Information
13
13
Irritation
13
13
Inflammation
12
12
Reaction
12
12
Nausea
11
11
Skin Infection
11
11
No Code Available
11
11
Burning Sensation
10
10
Nasal Obstruction
9
9
Fatigue
8
8
Fever
8
8
Aspiration/Inhalation
8
8
Discomfort
7
7
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
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
Malaise
3
3
Viral Infection
3
3
Respiratory Distress
3
3
Apnea
3
3
Hemorrhage/Bleeding
3
3
High Blood Pressure/ Hypertension
3
3
Hypersensitivity/Allergic reaction
2
2
Memory Loss/Impairment
2
2
Myocardial Infarction
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
Complaint, Ill-Defined
2
2
Unspecified Tissue Injury
2
2
Contact Dermatitis
2
2
Unspecified Eye / Vision Problem
2
2
Caustic/Chemical Burns
2
2
Lethargy
2
2
Weight Changes
2
2
Tissue Breakdown
1
1
Alteration In Body Temperature
1
1
Superficial (First Degree) Burn
1
1
Chemical Exposure
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
Numbness
1
1
Ulcer
1
1
Choking
1
1
Irritability
1
1
Sensitivity of Teeth
1
1
Diaphoresis
1
1
Excessive Tear Production
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Blurred Vision
1
1
Visual Disturbances
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
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