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TPLC
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show TPLC since
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2024
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Device
device, cystometric, hydraulic
Product Code
FEN
Regulation Number
876.1620
Device Class
2
Premarket Reviews
Manufacturer
Decision
SRS MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
11
11
2015
33
33
2016
10
10
2017
3
3
2018
2
2
2019
6
6
2021
1
1
2022
3
3
2023
3
3
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
9
9
No Flow
9
9
Deflation Problem
9
9
Calibration Problem
5
5
Material Protrusion/Extrusion
4
4
Device Operates Differently Than Expected
4
4
Defective Component
4
4
Partial Blockage
3
3
Output Problem
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Obstruction of Flow
3
3
Infusion or Flow Problem
3
3
Blocked Connection
3
3
Break
2
2
No Device Output
2
2
Inflation Problem
2
2
Crack
2
2
Disconnection
2
2
Gas/Air Leak
1
1
Scratched Material
1
1
High Readings
1
1
Device Difficult to Program or Calibrate
1
1
Difficult to Open or Close
1
1
Display or Visual Feedback Problem
1
1
Device Displays Incorrect Message
1
1
Defective Device
1
1
Deformation Due to Compressive Stress
1
1
Display Difficult to Read
1
1
Loss of or Failure to Bond
1
1
Fluid/Blood Leak
1
1
Hole In Material
1
1
Torn Material
1
1
Device Dislodged or Dislocated
1
1
Increase in Pressure
1
1
Device Operational Issue
1
1
Device Slipped
1
1
Detachment of Device or Device Component
1
1
Reset Problem
1
1
Sticking
1
1
Connection Problem
1
1
Device Or Device Fragments Location Unknown
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
39
39
No Clinical Signs, Symptoms or Conditions
10
10
Urinary Retention
9
9
No Information
4
4
Insufficient Information
2
2
Pain
2
2
Hemorrhage/Bleeding
2
2
Vessel Or Plaque, Device Embedded In
1
1
High Blood Pressure/ Hypertension
1
1
Death
1
1
No Code Available
1
1
Obstruction/Occlusion
1
1
Abrasion
1
1
Foreign Body In Patient
1
1
Discomfort
1
1
Anxiety
1
1
Tissue Damage
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ConvaTec, Inc
II
Aug-10-2018
2
LABORIE MEDICAL TECHNOLOGIES, CORP
II
Jul-25-2019
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