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TPLC
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show TPLC since
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Device
bag, urinary, ileostomy
Product Code
EXH
Regulation Number
876.5900
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
88
88
2015
27
27
2016
9
9
2018
112
112
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
301
301
Adverse Event Without Identified Device or Use Problem
47
47
Occlusion Within Device
22
22
Fluid/Blood Leak
13
13
Material Disintegration
12
12
Appropriate Term/Code Not Available
11
11
No Flow
9
9
Positioning Problem
9
9
Human-Device Interface Problem
9
9
Sharp Edges
8
8
Deflation Problem
7
7
Device Operates Differently Than Expected
6
6
Difficult to Remove
5
5
Leak/Splash
4
4
Insufficient Information
4
4
Increased Sensitivity
2
2
Blocked Connection
2
2
Connection Problem
2
2
Partial Blockage
2
2
Complete Blockage
2
2
Crack
1
1
Loss of or Failure to Bond
1
1
Break
1
1
Failure To Adhere Or Bond
1
1
Material Erosion
1
1
Product Quality Problem
1
1
Reflux within Device
1
1
Material Separation
1
1
Sticking
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Insufficient Flow or Under Infusion
1
1
Defective Component
1
1
Delamination
1
1
Split
1
1
Defective Device
1
1
Device Contamination with Chemical or Other Material
1
1
Material Integrity Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
252
252
No Known Impact Or Consequence To Patient
47
47
No Patient Involvement
46
46
No Clinical Signs, Symptoms or Conditions
28
28
Rash
23
23
Itching Sensation
14
14
Tissue Damage
14
14
Urinary Tract Infection
10
10
Erythema
10
10
Skin Discoloration
8
8
Blood Loss
8
8
Skin Irritation
7
7
Discomfort
6
6
Laceration(s)
6
6
Pain
6
6
Irritation
5
5
Burning Sensation
5
5
Skin Erosion
3
3
Hemorrhage/Bleeding
3
3
Skin Tears
3
3
Fungal Infection
3
3
Skin Inflammation
3
3
Tissue Breakdown
2
2
No Information
2
2
Unspecified Infection
2
2
Fungus
2
2
Bacterial Infection
2
2
Cellulitis
1
1
Fever
1
1
Hematoma
1
1
Inflammation
1
1
Abrasion
1
1
Sepsis
1
1
Peeling
1
1
Swelling
1
1
Vomiting
1
1
Ulceration
1
1
Urinary Retention
1
1
Chills
1
1
Reaction
1
1
Wheal(s)
1
1
Ulcer
1
1
Urticaria
1
1
Skin Infection
1
1
Skin Inflammation/ Irritation
1
1
Diaphoresis
1
1
Obstruction/Occlusion
1
1
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