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TPLC
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show TPLC since
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Device
unit, cryotherapy, ophthalmic
Product Code
HQA
Regulation Number
886.4170
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
21
21
2020
9
9
2021
15
15
2022
5
5
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Temperature Problem
11
11
Therapeutic or Diagnostic Output Failure
5
5
Excessive Cooling
5
5
Leak/Splash
5
5
Material Fragmentation
4
4
Pressure Problem
4
4
Defective Component
3
3
Break
3
3
Suction Problem
2
2
Mechanical Problem
2
2
Structural Problem
2
2
Defective Device
2
2
Detachment of Device or Device Component
2
2
Output Problem
2
2
Physical Resistance/Sticking
2
2
Appropriate Term/Code Not Available
1
1
Material Split, Cut or Torn
1
1
Infusion or Flow Problem
1
1
Material Twisted/Bent
1
1
Device Displays Incorrect Message
1
1
Calibration Problem
1
1
Increase in Pressure
1
1
Material Puncture/Hole
1
1
Unable to Obtain Readings
1
1
Difficult to Remove
1
1
Material Rupture
1
1
Failure to Read Input Signal
1
1
Device Damaged Prior to Use
1
1
Insufficient Heating
1
1
Excess Flow or Over-Infusion
1
1
Intermittent Continuity
1
1
Insufficient Cooling
1
1
Flaked
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
24
24
Insufficient Information
17
17
No Clinical Signs, Symptoms or Conditions
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Information
1
1
No Consequences Or Impact To Patient
1
1
Chemical Exposure
1
1
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