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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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Device
catheter, retention, barium enema with bag
Product Code
FGD
Regulation Number
876.5980
Device Class
2
Premarket Reviews
Manufacturer
Decision
CHESS MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2017
4
4
2019
1
1
2020
1
1
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Deflation Problem
4
4
Leak/Splash
3
3
Defective Component
2
2
Off-Label Use
1
1
Use of Device Problem
1
1
Material Deformation
1
1
Detachment of Device or Device Component
1
1
Device Dislodged or Dislocated
1
1
Component Falling
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
4
4
No Code Available
3
3
Hemorrhage/Bleeding
2
2
Hypersensitivity/Allergic reaction
1
1
Skin Inflammation/ Irritation
1
1
Embolism/Embolus
1
1
Chemical Exposure
1
1
Injury
1
1
Foreign Body In Patient
1
1
Pain
1
1
Skin Tears
1
1
No Consequences Or Impact To Patient
1
1
Device Embedded In Tissue or Plaque
1
1
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