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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cyclosporine
Product CodeMKW
Regulation Number 862.1235
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 2 2
2021 6 6
2022 7 7
2023 5 5
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 16 16
High Test Results 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
No Known Impact Or Consequence To Patient 6 6
Insufficient Information 1 1
Convulsion/Seizure 1 1

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