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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pad, neonatal eye
Product CodeFOK
Regulation Number 880.5270
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 8 8
2017 3 3
2018 1 1
2019 2 2
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Emits Odor 5 5
Use of Device Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 3 3
Improper or Incorrect Procedure or Method 3 3
Device Slipped 2 2
Material Integrity Problem 2 2
Component Falling 1 1
Sticking 1 1
Component Missing 1 1
Malposition of Device 1 1
Device Operates Differently Than Expected 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 6 6
Airway Obstruction 4 4
Obstruction/Occlusion 3 3
No Information 2 2
No Code Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
No Known Impact Or Consequence To Patient 1 1
Apnea 1 1
Skin Erosion 1 1

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