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TPLC
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show TPLC since
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Device
valvulotome
Product Code
MGZ
Regulation Number
870.4885
Device Class
2
Premarket Reviews
Manufacturer
Decision
LEMAITRE VASCULAR
SUBSTANTIALLY EQUIVALENT
1
LIMFLOW, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
7
7
2019
19
19
2020
6
6
2021
2
2
2022
13
13
2023
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult to Open or Close
23
23
Retraction Problem
18
18
Adverse Event Without Identified Device or Use Problem
9
9
Failure to Align
5
5
Material Deformation
4
4
Material Twisted/Bent
2
2
Connection Problem
2
2
Break
2
2
Fluid/Blood Leak
1
1
Difficult to Flush
1
1
Leak/Splash
1
1
Failure to Cut
1
1
Material Separation
1
1
Defective Component
1
1
Device Markings/Labelling Problem
1
1
Flare or Flash
1
1
Positioning Problem
1
1
Insufficient Information
1
1
Bent
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
20
20
No Known Impact Or Consequence To Patient
15
15
Perforation of Vessels
13
13
Laceration(s)
6
6
No Information
4
4
Insufficient Information
3
3
No Patient Involvement
3
3
No Consequences Or Impact To Patient
3
3
Injury
1
1
Blood Loss
1
1
Foreign Body In Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
LeMaitre Vascular, Inc.
II
Aug-28-2023
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