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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, cryotherapy, ophthalmic
Regulation Description Cryophthalmic unit.
Product CodeHQA
Regulation Number 886.4170
Device Class 2

MDR Year MDR Reports MDR Events
2020 9 9
2021 15 15
2022 5 5
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Temperature Problem 7 7
Leak/Splash 5 5
Material Fragmentation 4 4
Pressure Problem 3 3
Excessive Cooling 3 3
Break 2 2
Output Problem 2 2
Physical Resistance/Sticking 2 2
Defective Component 2 2
Defective Device 2 2
Suction Problem 2 2
Material Split, Cut or Torn 1 1
Mechanical Problem 1 1
Device Damaged Prior to Use 1 1
Material Puncture/Hole 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult to Remove 1 1
Unable to Obtain Readings 1 1
Excess Flow or Over-Infusion 1 1
Structural Problem 1 1
Infusion or Flow Problem 1 1
Calibration Problem 1 1
Detachment of Device or Device Component 1 1
Increase in Pressure 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
Insufficient Information 17 17
No Clinical Signs, Symptoms or Conditions 8 8
No Known Impact Or Consequence To Patient 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Chemical Exposure 1 1

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