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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
Product CodeLHC
Regulation Number 890.5950
Device Class 1

MDR Year MDR Reports MDR Events
2018 30 30
2019 8 8
2020 4 4
2021 5 5
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Hole In Material 16 16
Material Puncture/Hole 10 10
Sharp Edges 5 5
Crack 4 4
Fluid/Blood Leak 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Temperature Problem 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
No Display/Image 1 1
Failure to Read Input Signal 1 1
Inadequate or Insufficient Training 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Infusion or Flow Problem 1 1
Leak/Splash 1 1
Mechanical Problem 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 29 29
Laceration(s) 5 5
No Consequences Or Impact To Patient 5 5
No Clinical Signs, Symptoms or Conditions 4 4
No Patient Involvement 2 2
No Information 2 2
Physical Entrapment 1 1
Abrasion 1 1
Hemorrhage/Bleeding 1 1

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