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TPLC
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show TPLC since
2009
2010
2011
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2014
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2016
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2019
2020
2021
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2024
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Device
applicator, ent
Product Code
KCJ
Regulation Number
874.5220
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
2
2
2016
2
2
2017
2
2
2018
1
1
2019
3
3
2020
1
1
2021
2
2
2022
3
3
2023
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Device Operates Differently Than Expected
2
2
Insufficient Information
2
2
Product Quality Problem
2
2
Improper or Incorrect Procedure or Method
1
1
Device Or Device Fragments Location Unknown
1
1
Patient-Device Incompatibility
1
1
Detachment Of Device Component
1
1
Material Discolored
1
1
Fire
1
1
Material Fragmentation
1
1
Mechanical Problem
1
1
Device Emits Odor
1
1
Patient Device Interaction Problem
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Contamination with Chemical or Other Material
1
1
Positioning Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
6
6
Burning Sensation
4
4
Hemorrhage/Bleeding
3
3
Dizziness
3
3
Hypersensitivity/Allergic reaction
2
2
Insufficient Information
2
2
No Clinical Signs, Symptoms or Conditions
1
1
Chills
1
1
Device Embedded In Tissue or Plaque
1
1
Convulsion/Seizure
1
1
Swelling/ Edema
1
1
Death
1
1
Diarrhea
1
1
Fall
1
1
Fatigue
1
1
Head Injury
1
1
Headache
1
1
Itching Sensation
1
1
Nausea
1
1
Pain
1
1
Perforation
1
1
Blurred Vision
1
1
Vomiting
1
1
No Consequences Or Impact To Patient
1
1
Discomfort
1
1
Injury
1
1
Disability
1
1
Sore Throat
1
1
Loss of consciousness
1
1
Fungal Infection
1
1
Foreign Body In Patient
1
1
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