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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
2018 3 3
2019 4 4
2020 2 2
2021 6 6
2022 7 7
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 17 17
High Test Results 8 8
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 9 9
Convulsion/Seizure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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