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TPLC
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show TPLC since
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Device
graft, vascular, synthetic/biologic composite
Product Code
MAL
Regulation Number
870.3450
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
28
28
2020
24
24
2021
34
34
2022
21
21
2023
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
Product Quality Problem
20
20
Adverse Event Without Identified Device or Use Problem
16
16
Nonstandard Device
15
15
Material Puncture/Hole
12
12
Material Frayed
9
9
Manufacturing, Packaging or Shipping Problem
9
9
Device Damaged Prior to Use
7
7
Off-Label Use
6
6
Device Contaminated During Manufacture or Shipping
6
6
Material Integrity Problem
5
5
Shipping Damage or Problem
5
5
Stretched
4
4
Flaked
4
4
Inaccurate Information
4
4
Use of Device Problem
3
3
Improper or Incorrect Procedure or Method
2
2
Device Contaminated at the User Facility
2
2
Patient Device Interaction Problem
2
2
No Apparent Adverse Event
2
2
Insufficient Information
2
2
Appropriate Term/Code Not Available
1
1
Therapeutic or Diagnostic Output Failure
1
1
Material Perforation
1
1
Material Twisted/Bent
1
1
Contamination /Decontamination Problem
1
1
Material Rupture
1
1
Leak/Splash
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
40
40
Hemorrhage/Bleeding
21
21
No Patient Involvement
13
13
No Consequences Or Impact To Patient
11
11
Blood Loss
9
9
Insufficient Information
7
7
No Known Impact Or Consequence To Patient
6
6
Pseudoaneurysm
4
4
Fungal Infection
4
4
Bacterial Infection
4
4
Paraplegia
2
2
Stenosis
2
2
No Information
2
2
Ventricular Fibrillation
2
2
Cancer
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hemolytic Anemia
1
1
Death
1
1
Exsanguination
1
1
Failure of Implant
1
1
Renal Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GETINGE US SALES LLC
II
Sep-24-2019
2
Maquet Cardiovascular, LLC
II
Mar-07-2022
3
Maquet Cardiovascular, LLC
II
Dec-20-2021
4
Maquet Cardiovascular, LLC
II
May-04-2020
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