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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device olive oil emulsion (turbidimetric), lipase
Product CodeCET
Regulation Number 862.1465
Device Class 1

MDR Year MDR Reports MDR Events
2022 4 4
2023 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 22 22
Mechanical Problem 8 8
Fracture 4 4
Unintended Movement 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Spinal Column Injury 4 4

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