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TPLC
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Device
system, vocal cord medialization
Product Code
MIX
Regulation Number
874.3620
Device Class
2
Premarket Reviews
Manufacturer
Decision
COAPT SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
CYTOPHIL INC
SUBSTANTIALLY EQUIVALENT
3
1. K081815
VOCALIS GEL
2. K081816
VOCALIS AND VOCALIS SM
3. K121795
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
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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