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TPLC
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show TPLC since
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Device
tray, surgical
Product Code
LRP
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
8
8
2019
6
6
2020
5
5
2021
3
3
2022
10
10
2023
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
10
10
Appropriate Term/Code Not Available
4
4
Component Missing
2
2
Contamination /Decontamination Problem
2
2
Unraveled Material
2
2
Device Dislodged or Dislocated
2
2
Device Contamination with Chemical or Other Material
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Deformation
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Output Problem
1
1
Insufficient Information
1
1
Device Contaminated During Manufacture or Shipping
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Detachment of Device or Device Component
1
1
Device Contamination With Biological Material
1
1
Device Damaged by Another Device
1
1
Difficult to Open or Remove Packaging Material
1
1
Crack
1
1
Fire
1
1
Difficult to Insert
1
1
Retraction Problem
1
1
Material Separation
1
1
Sharp Edges
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
11
11
No Known Impact Or Consequence To Patient
8
8
Foreign Body In Patient
6
6
Insufficient Information
4
4
No Patient Involvement
4
4
Needle Stick/Puncture
2
2
No Information
2
2
Cerebrospinal Fluid Leakage
1
1
Unspecified Infection
1
1
Laceration(s)
1
1
No Consequences Or Impact To Patient
1
1
Rupture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
II
Sep-25-2020
2
Cardinal Health 200, LLC
II
Jul-18-2018
3
Centurion Medical Products Corporation
II
Feb-05-2020
4
Centurion Medical Products Corporation
II
Oct-31-2019
5
Centurion Medical Products Corporation
II
Oct-09-2019
6
Centurion Medical Products Corporation
II
Aug-06-2019
7
Centurion Medical Products Corporation
II
Mar-17-2018
8
MEDLINE INDUSTRIES, LP - Northfield
II
Aug-03-2023
9
MEDLINE INDUSTRIES, LP - Northfield
II
Jul-20-2023
10
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-10-2023
11
MEDLINE INDUSTRIES, LP - Northfield
II
Nov-01-2022
12
Medline Industries Inc
II
Jan-25-2020
13
Medline Industries Inc.
II
Sep-07-2022
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