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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cover, shoe, operating-room
Product CodeFXP
Regulation Number 878.4040
Device Class 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 2 2
2016 2 2
2018 1 1
2019 3 3
2021 1 1
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 4 4
Product Quality Problem 2 2
Device Operates Differently Than Expected 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Structural Problem 1 1
Material Puncture/Hole 1 1
Particulates 1 1
Appropriate Term/Code Not Available 1 1
Material Disintegration 1 1
Human-Device Interface Problem 1 1
Material Integrity Problem 1 1
Defective Device 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 8 8
Bone Fracture(s) 2 2
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Damage to Ligament(s) 1 1
Fracture, Arm 1 1
Injury 1 1
Pain 1 1

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