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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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Device
gauze/sponge, internal
Product Code
EFQ
Device Class
Unclassified
MDR Year
MDR Reports
MDR Events
2019
5
5
2020
8
8
2021
6
6
2022
6
6
2023
10
10
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
8
8
Adverse Event Without Identified Device or Use Problem
6
6
Material Frayed
4
4
Component Missing
4
4
Material Integrity Problem
3
3
Detachment of Device or Device Component
3
3
Break
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Difficult to Remove
2
2
Material Fragmentation
2
2
Unraveled Material
2
2
Packaging Problem
2
2
Separation Problem
1
1
Entrapment of Device
1
1
Device Markings/Labelling Problem
1
1
Material Disintegration
1
1
Insufficient Information
1
1
Device Fell
1
1
Contamination /Decontamination Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Protective Measures Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Loss of or Failure to Bond
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
12
12
No Known Impact Or Consequence To Patient
7
7
Unspecified Infection
6
6
Insufficient Information
6
6
Foreign Body In Patient
4
4
Adhesion(s)
1
1
Itching Sensation
1
1
No Patient Involvement
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ROi CPS LLC
II
Dec-28-2020
2
Steris Corporation
II
May-20-2022
3
TELEFLEX LLC
II
Dec-28-2022
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