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TPLC
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show TPLC since
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Device
device, specimen collection
Product Code
LIO
Regulation Number
866.2900
Device Class
1
Premarket Reviews
Manufacturer
Decision
ARX SCIENCES, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD
SUBSTANTIALLY EQUIVALENT
1
PURITAN MEDICAL PRODUCTS LLC
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
7
7
2015
2
2
2016
5
5
2017
6
6
2018
8
8
2019
2
2
2020
3
3
2021
11
11
2022
1
1
2023
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
9
9
Adverse Event Without Identified Device or Use Problem
7
7
Product Quality Problem
6
6
Leak/Splash
5
5
Insufficient Information
4
4
Material Protrusion/Extrusion
3
3
Improper or Incorrect Procedure or Method
3
3
Manufacturing, Packaging or Shipping Problem
2
2
Entrapment of Device
1
1
Device Markings/Labelling Problem
1
1
Disconnection
1
1
Scratched Material
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Fluid/Blood Leak
1
1
Detachment of Device or Device Component
1
1
Nonstandard Device
1
1
Defective Device
1
1
Human Factors Issue
1
1
Device Handling Problem
1
1
Device Contamination With Biological Material
1
1
Chemical Spillage
1
1
Material Integrity Problem
1
1
Contamination
1
1
Human-Device Interface Problem
1
1
Difficult to Open or Close
1
1
Use of Device Problem
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
12
12
Exposure to Body Fluids
8
8
Laceration(s)
6
6
No Clinical Signs, Symptoms or Conditions
6
6
Needle Stick/Puncture
5
5
No Consequences Or Impact To Patient
4
4
Insufficient Information
2
2
Foreign Body In Patient
2
2
No Known Impact Or Consequence To Patient
2
2
Device Embedded In Tissue or Plaque
2
2
No Information
2
2
Chemical Exposure
2
2
Headache
2
2
Unspecified Infection
2
2
Chest Pain
1
1
Eye Injury
1
1
Blood Loss
1
1
No Code Available
1
1
Abrasion
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Remel, Inc
III
Aug-18-2009
2
Thomas Scientific
II
Nov-13-2020
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