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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, vocal cord medialization
Regulation Description Ear, nose, and throat synthetic polymer material.
Product CodeMIX
Regulation Number 874.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
SOFREGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 5 5
2023 4 4
2024 2 2
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Deliver 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Swelling/ Edema 4 4
No Clinical Signs, Symptoms or Conditions 2 2
Necrosis 2 2
Dyspnea 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
Breast Cancer 1 1
Inflammation 1 1
Autoimmune Disorder 1 1
Foreign Body In Patient 1 1
Discomfort 1 1
Airway Obstruction 1 1
Hyperemia 1 1
Ventilator Dependent 1 1

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