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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device forceps, ent
Product CodeKAE
Regulation Number 874.4420
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2021 4 4
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Device Reprocessing Problem 2 2
Material Fragmentation 1 1
Mechanical Problem 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Close 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 2 2
Cerebrospinal Fluid Leakage 1 1
Brain Injury 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1

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