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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
2015 1 1
2018 1 1
2019 1 1
2022 7 7
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 9 9
Leak/Splash 3 3
Product Quality Problem 2 2
Device Damaged Prior to Use 2 2
Device Markings/Labelling Problem 2 2
Component Missing 1 1
Chemical Spillage 1 1
Contamination of Device Ingredient or Reagent 1 1
Material Discolored 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
Respiratory Distress 1 1
Injury 1 1
Chemical Exposure 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Richard-Allan Scientific Company II Aug-05-2016
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