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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device slides, microscope
Product CodeKEW
Regulation Number 864.3010
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 14 14
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Off-Label Use 14 14
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Deformation 1 1
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 15 15
No Known Impact Or Consequence To Patient 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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