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TPLC
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Device
legging, compression, non-inflatable
Product Code
LLK
Regulation Number
880.5780
Device Class
2
MDR Year
MDR Reports
MDR Events
2015
6
6
2016
14
14
2018
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Improper or Incorrect Procedure or Method
4
4
Aspiration Issue
3
3
Human-Device Interface Problem
3
3
Material Integrity Problem
2
2
Fluid/Blood Leak
2
2
Device Ingredient or Reagent Problem
1
1
Migration or Expulsion of Device
1
1
Volume Accuracy Problem
1
1
Communication or Transmission Problem
1
1
Kinked
1
1
Patient-Device Incompatibility
1
1
Excess Flow or Over-Infusion
1
1
Insufficient Flow or Under Infusion
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Operates Differently Than Expected
1
1
Device Or Device Fragments Location Unknown
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
7
7
Muscular Rigidity
3
3
Underdose
3
3
Therapeutic Effects, Unexpected
2
2
Hypersensitivity/Allergic reaction
1
1
Muscle Weakness
1
1
Malaise
1
1
Overdose
1
1
Confusion/ Disorientation
1
1
Rash
1
1
Therapeutic Response, Decreased
1
1
Meningitis
1
1
Urinary Tract Infection
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Customed, Inc
I
Dec-16-2014
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