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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device warmer, irrigation solution
Regulation Description Powered heating unit.
Product CodeLHC
Regulation Number 890.5950
Device Class 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 5 5
2022 1 1
2024 5 5
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 6 6
Material Puncture/Hole 5 5
Leak/Splash 2 2
Defective Device 2 2
Failure to Read Input Signal 1 1
Mechanical Problem 1 1
Contamination /Decontamination Problem 1 1
Failure to Power Up 1 1
Precipitate in Device or Device Ingredient 1 1
Flare or Flash 1 1
No Apparent Adverse Event 1 1
Power Problem 1 1
Insufficient Cooling 1 1
Fluid/Blood Leak 1 1
Temperature Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Laceration(s) 5 5
No Known Impact Or Consequence To Patient 2 2
Abrasion 1 1
Insufficient Information 1 1
Hemorrhage/Bleeding 1 1

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