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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
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 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Structural Problem 1 1
Material Integrity Problem 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 3 3
Bone Fracture(s) 1 1
Damage to Ligament(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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