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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device pad, neonatal eye
Product CodeFOK
Regulation Number 880.5270
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 2 2
Insufficient Information 2 2
Improper or Incorrect Procedure or Method 1 1
Malposition of Device 1 1

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

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