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TPLC
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Device
device, urine flow rate measuring, non-electrical, disposable
Product Code
FFG
Regulation Number
876.1800
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
9
9
2020
92
92
2021
109
109
2022
21
21
2023
6
6
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
178
178
Obstruction of Flow
19
19
No Flow
15
15
Infusion or Flow Problem
6
6
Material Integrity Problem
5
5
Break
4
4
Material Separation
4
4
Disconnection
3
3
Contamination /Decontamination Problem
3
3
Device Contamination with Chemical or Other Material
3
3
Crack
1
1
Connection Problem
1
1
Unintended Deflation
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
132
132
No Consequences Or Impact To Patient
65
65
Insufficient Information
16
16
Urinary Retention
13
13
No Known Impact Or Consequence To Patient
6
6
No Information
4
4
Foreign Body In Patient
4
4
No Patient Involvement
4
4
Pain
4
4
Abdominal Distention
2
2
Obstruction/Occlusion
2
2
Discomfort
2
2
Unspecified Mental, Emotional or Behavioural Problem
1
1
Burning Sensation
1
1
Urinary Tract Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
I
Feb-16-2024
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