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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
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2020
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2024
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Device
bag, urinary, ileostomy
Product Code
EXH
Regulation Number
876.5900
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
93
93
2020
89
89
2021
2
2
2022
10
10
2023
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Malposition of Device
190
190
Material Disintegration
12
12
Positioning Problem
9
9
Fluid/Blood Leak
9
9
Sharp Edges
8
8
Adverse Event Without Identified Device or Use Problem
4
4
Insufficient Information
2
2
Complete Blockage
2
2
Material Erosion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
162
162
No Clinical Signs, Symptoms or Conditions
28
28
No Patient Involvement
12
12
Discomfort
6
6
Tissue Damage
6
6
Laceration(s)
6
6
Blood Loss
5
5
Hemorrhage/Bleeding
3
3
Urinary Tract Infection
3
3
Erythema
2
2
Cellulitis
1
1
Itching Sensation
1
1
Pain
1
1
Peeling
1
1
Rash
1
1
Swelling
1
1
Burning Sensation
1
1
Chills
1
1
Diaphoresis
1
1
Skin Tears
1
1
Tissue Breakdown
1
1
Skin Infection
1
1
Skin Inflammation/ Irritation
1
1
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