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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
Product CodeMIX
Regulation Number 874.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
COAPT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CYTOPHIL INC
  SUBSTANTIALLY EQUIVALENT 3
CYTOPHIL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOFREGEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 1 1
2017 3 3
2018 5 5
2019 1 1
2020 10 10
2021 5 5
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21 21
Insufficient Information 7 7
Patient-Device Incompatibility 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Difficult or Delayed Positioning 1 1
Leak/Splash 1 1
Delivered as Unsterile Product 1 1
Short Fill 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Deliver 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 7 7
Dyspnea 4 4
Inflammation 4 4
Swelling/ Edema 4 4
Dysphagia/ Odynophagia 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Swelling 2 2
No Consequences Or Impact To Patient 2 2
Discomfort 2 2
Complaint, Ill-Defined 2 2
No Code Available 2 2
Edema 2 2
Erythema 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Hyperemia 1 1
Hypersensitivity/Allergic reaction 1 1
Itching Sensation 1 1
Muscular Rigidity 1 1
Necrosis 1 1
Paralysis 1 1
Rash 1 1
Respiratory Distress 1 1
Ventilator Dependent 1 1
Neck Pain 1 1
Reaction, Injection Site 1 1
Nasal Obstruction 1 1
Increased Respiratory Rate 1 1
Patient Problem/Medical Problem 1 1
No Information 1 1
Missing Value Reason 1 1
Therapeutic Response, Decreased 1 1
Abscess 1 1
Airway Obstruction 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Merz North America, Inc. II Dec-03-2015
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