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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
Regulation Description Surgical apparel.
Product CodeFXP
Regulation Number 878.4040
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 2 2
2024 7 7
2025 36 36
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Unsafe to Use in Environment 41 41
Device Slipped 2 2
Product Quality Problem 2 2
Material Puncture/Hole 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 23 23
No Clinical Signs, Symptoms or Conditions 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Bone Fracture(s) 2 2
Concussion 1 1
Limb Fracture 1 1

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