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TPLC
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show TPLC since
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2024
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Device
balloon, epistaxis
Product Code
EMX
Regulation Number
874.4100
Device Class
1
Premarket Reviews
Manufacturer
Decision
HEMOSTASIS LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
12
12
2020
5
5
2021
2
2
2023
3
3
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
7
7
Break
6
6
Insufficient Information
6
6
Improper or Incorrect Procedure or Method
5
5
Material Rupture
3
3
Material Discolored
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Material Split, Cut or Torn
1
1
Decrease in Pressure
1
1
Inflation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
10
10
Injury
9
9
Abrasion
5
5
Hemorrhage/Bleeding
4
4
Pain
3
3
Blood Loss
2
2
Epistaxis
2
2
Vomiting
2
2
Dyspnea
2
2
No Code Available
1
1
Perforation
1
1
Fever
1
1
Foreign Body In Patient
1
1
Insufficient Information
1
1
Unspecified Tissue Injury
1
1
Swelling/ Edema
1
1
Airway Obstruction
1
1
Low Oxygen Saturation
1
1
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