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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device formalin, neutral buffered
Product CodeIFP
Regulation Number 864.4010
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2022 7 7
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 9 9
Product Quality Problem 2 2
Device Markings/Labelling Problem 2 2
Device Damaged Prior to Use 1 1
Component Missing 1 1
Contamination of Device Ingredient or Reagent 1 1
Material Discolored 1 1
Leak/Splash 1 1
Break 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 9 9
No Clinical Signs, Symptoms or Conditions 6 6
Pain 1 1
Injury 1 1

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