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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
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Restricted Flow rate
97
97
Component Missing
28
28
Biocompatibility
15
15
Deformation Due to Compressive Stress
13
13
No Flow
8
8
Fluid/Blood Leak
8
8
Adverse Event Without Identified Device or Use Problem
7
7
Component Misassembled
6
6
Partial Blockage
5
5
Material Twisted/Bent
5
5
Obstruction of Flow
5
5
Kinked
4
4
Patient-Device Incompatibility
3
3
Complete Blockage
3
3
Physical Resistance/Sticking
3
3
Disconnection
3
3
Device Operates Differently Than Expected
3
3
Nonstandard Device
3
3
Material Rupture
3
3
Infusion or Flow Problem
2
2
Leak/Splash
2
2
Improper Flow or Infusion
2
2
Insufficient Information
2
2
Inadequate Instructions for Healthcare Professional
2
2
No Apparent Adverse Event
2
2
Inaccurate Flow Rate
1
1
Folded
1
1
Occlusion Within Device
1
1
Difficult to Open or Close
1
1
Device Inoperable
1
1
Device Contaminated During Manufacture or Shipping
1
1
Hole In Material
1
1
Failure To Service
1
1
Collapse
1
1
Fungus in Device Environment
1
1
Filling Problem
1
1
Inadequate or Insufficient Training
1
1
Wrong Label
1
1
Defective Component
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Microbial Contamination of Device
1
1
Material Fragmentation
1
1
Sticking
1
1
Labelling, Instructions for Use or Training Problem
1
1
Unexpected Therapeutic Results
1
1
Incorrect Measurement
1
1
Detachment of Device or Device Component
1
1
Inflation Problem
1
1
Tear, Rip or Hole in Device Packaging
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
145
145
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
No Information
5
5
Urinary Retention
5
5
Discomfort
5
5
Unspecified Infection
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
No Patient Involvement
3
3
Insufficient Information
3
3
Patient Problem/Medical Problem
1
1
Skin Irritation
1
1
No Code Available
1
1
Skin Inflammation/ Irritation
1
1
Burn(s)
1
1
Rash
1
1
Bacterial Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Teleflex Medical
II
Jun-27-2011
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