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TPLC
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show TPLC since
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Device
bag, urine collection, leg, for external use, sterile
Product Code
FAQ
Regulation Number
876.5250
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
1
1
2016
13
13
2017
22
22
2018
3
3
2019
3
3
2020
1
1
2021
70
70
2022
48
48
2023
36
36
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Restricted Flow rate
79
79
Component Missing
28
28
Biocompatibility
15
15
Deformation Due to Compressive Stress
8
8
Fluid/Blood Leak
8
8
No Flow
8
8
Adverse Event Without Identified Device or Use Problem
7
7
Component Misassembled
6
6
Material Twisted/Bent
5
5
Obstruction of Flow
5
5
Kinked
4
4
Nonstandard Device
3
3
Patient-Device Incompatibility
3
3
Device Operates Differently Than Expected
3
3
Partial Blockage
3
3
Disconnection
3
3
Material Rupture
3
3
Physical Resistance/Sticking
3
3
No Apparent Adverse Event
2
2
Insufficient Information
2
2
Improper Flow or Infusion
2
2
Infusion or Flow Problem
2
2
Complete Blockage
2
2
Inadequate Instructions for Healthcare Professional
2
2
Leak/Splash
2
2
Incorrect Measurement
1
1
Inaccurate Flow Rate
1
1
Occlusion Within Device
1
1
Fungus in Device Environment
1
1
Tear, Rip or Hole in Device Packaging
1
1
Folded
1
1
Difficult to Open or Close
1
1
Device Contamination with Chemical or Other Material
1
1
Detachment of Device or Device Component
1
1
Collapse
1
1
Filling Problem
1
1
Hole In Material
1
1
Inflation Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Material Separation
1
1
Failure To Service
1
1
Sticking
1
1
Unexpected Therapeutic Results
1
1
Inadequate or Insufficient Training
1
1
Device Inoperable
1
1
Defective Component
1
1
Microbial Contamination of Device
1
1
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Handling Problem
1
1
Illegible Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
119
119
Urinary Tract Infection
26
26
No Known Impact Or Consequence To Patient
25
25
No Consequences Or Impact To Patient
10
10
Sepsis
8
8
Urinary Retention
5
5
No Information
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Insufficient Information
3
3
Unspecified Infection
3
3
Discomfort
3
3
No Patient Involvement
3
3
No Code Available
1
1
Burn(s)
1
1
Rash
1
1
Skin Irritation
1
1
Skin Inflammation/ Irritation
1
1
Bacterial Infection
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Teleflex Medical
II
Jun-27-2011
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