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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stocking, medical support (for general medical purposes)
Regulation Description Medical support stocking.
Product CodeFQL
Regulation Number 880.5780
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 1 1
2018 1 1
2019 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 3 3
Data Problem 2 2
Material Deformation 1 1
Material Integrity Problem 1 1
Fire 1 1
Patient-Device Incompatibility 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 3 3
Burn(s) 1 1
Swelling 1 1
Pain 1 1
Complaint, Ill-Defined 1 1
Injury 1 1

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