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TPLC
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show TPLC since
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2024
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Device
light, catheter, fiberoptic, glass, ureteral
Product Code
FCS
Regulation Number
876.4020
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
4
4
2020
8
8
2021
6
6
2022
19
19
2023
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Packaging Problem
10
10
Adverse Event Without Identified Device or Use Problem
8
8
Output Problem
6
6
Device Contamination with Chemical or Other Material
6
6
Contamination /Decontamination Problem
5
5
Contamination
4
4
Device Unsafe to Use in Environment
4
4
Patient-Device Incompatibility
3
3
Insufficient Information
3
3
Use of Device Problem
3
3
Break
2
2
Expiration Date Error
2
2
Therapeutic or Diagnostic Output Failure
2
2
Structural Problem
2
2
Fracture
2
2
Device Contaminated During Manufacture or Shipping
1
1
Device Contamination with Body Fluid
1
1
Activation Problem
1
1
Device Markings/Labelling Problem
1
1
Difficult to Advance
1
1
Defective Device
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Delivered as Unsterile Product
1
1
Optical Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Nonstandard Device
1
1
Electrical /Electronic Property Problem
1
1
No Device Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
29
29
Insufficient Information
22
22
No Known Impact Or Consequence To Patient
7
7
Renal Failure
3
3
Genital Bleeding
2
2
Hemorrhage/Bleeding
2
2
Uterine Perforation
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Perforation
1
1
Blood Loss
1
1
Burn(s)
1
1
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