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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device legging, compression, non-inflatable
Product CodeLLK
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
Excess Flow or Over-Infusion 1 1
Kinked 1 1
Migration or Expulsion of Device 1 1
Volume Accuracy Problem 1 1
Insufficient Flow or Under Infusion 1 1
Device Or Device Fragments Location Unknown 1 1
Patient-Device Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Communication or Transmission Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
Underdose 3 3
Muscular Rigidity 3 3
Therapeutic Effects, Unexpected 2 2
Urinary Tract Infection 1 1
Therapeutic Response, Decreased 1 1
Malaise 1 1
Meningitis 1 1
Overdose 1 1
Rash 1 1
Hypersensitivity/Allergic reaction 1 1
Muscle Weakness 1 1
Confusion/ Disorientation 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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