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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
catheter, ureteral, general & plastic surgery
Product Code
GBL
Regulation Number
876.5130
Device Class
Not Classified
MDR Year
MDR Reports
MDR Events
2014
7
7
2015
8
8
2016
10
10
2017
25
25
2018
36
36
2019
15
15
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
27
27
Break
26
26
Device Contamination with Chemical or Other Material
8
8
Material Fragmentation
5
5
Detachment Of Device Component
4
4
Insufficient Information
4
4
Migration or Expulsion of Device
4
4
Contamination /Decontamination Problem
4
4
Fracture
3
3
Detachment of Device or Device Component
3
3
Flaked
2
2
Device Damaged Prior to Use
2
2
Peeled/Delaminated
2
2
Partial Blockage
2
2
Difficult to Remove
2
2
Tip breakage
2
2
Failure to Advance
2
2
Unraveled Material
2
2
Occlusion Within Device
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Obstruction of Flow
1
1
Material Puncture/Hole
1
1
Particulates
1
1
Appropriate Term/Code Not Available
1
1
Device Operates Differently Than Expected
1
1
Bent
1
1
Device Contaminated During Manufacture or Shipping
1
1
Protective Measures Problem
1
1
Material Too Rigid or Stiff
1
1
Unsealed Device Packaging
1
1
Kinked
1
1
Entrapment of Device
1
1
Difficult to Advance
1
1
Mechanical Problem
1
1
Crack
1
1
Packaging Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
32
32
No Known Impact Or Consequence To Patient
23
23
Foreign Body In Patient
12
12
No Patient Involvement
11
11
No Code Available
8
8
Device Embedded In Tissue or Plaque
6
6
Foreign body, removal of
6
6
No Information
4
4
Unspecified Infection
3
3
Internal Organ Perforation
2
2
Perforation
2
2
Insufficient Information
2
2
Thromboembolism
1
1
Erosion
1
1
Pain
1
1
Respiratory Failure
1
1
Surgical procedure, additional
1
1
Unknown (for use when the patient's condition is not known)
1
1
Nonresorbable materials, unretrieved in body
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
Feb-04-2020
2
Cook Inc.
II
Aug-22-2016
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