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TPLC
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show TPLC since
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2024
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Device
filiform and filiform follower
Product Code
FBW
Regulation Number
876.5520
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
1
1
2017
1
1
2018
14
14
2019
4
4
2020
1
1
2022
3
3
2023
17
17
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Handling Problem
12
12
Fitting Problem
12
12
Incorrect Measurement
9
9
Dull, Blunt
6
6
Component Missing
5
5
Manufacturing, Packaging or Shipping Problem
4
4
Burst Container or Vessel
2
2
Break
2
2
Material Deformation
2
2
Appropriate Term/Code Not Available
2
2
Entrapment of Device
1
1
Incomplete or Missing Packaging
1
1
Device Damaged Prior to Use
1
1
Expiration Date Error
1
1
Use of Device Problem
1
1
Positioning Failure
1
1
Structural Problem
1
1
Material Separation
1
1
Flaked
1
1
Material Fragmentation
1
1
Difficult to Insert
1
1
Material Rupture
1
1
Inflation Problem
1
1
Leak/Splash
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Inadequate Instructions for Healthcare Professional
1
1
Inadequate or Insufficient Training
1
1
Inaccurate Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
22
22
No Known Impact Or Consequence To Patient
12
12
No Consequences Or Impact To Patient
7
7
No Patient Involvement
6
6
Tissue Damage
4
4
Foreign Body In Patient
3
3
Injury
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Blood Loss
1
1
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