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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
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
Use of Device Problem 4 4
Device Slipped 2 2
Improper or Incorrect Procedure or Method 2 2
Insufficient Information 2 2
Malposition of Device 1 1

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

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