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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apron, leaded
Regulation Description Personnel protective shield.
Product CodeEAJ
Regulation Number 892.6500
Device Class 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 1 1
2023 4 4
2024 2 2
2025 4 4
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 3 3
Contamination /Decontamination Problem 3 3
Detachment of Device or Device Component 3 3
Material Integrity Problem 2 2
Break 1 1
Mechanical Problem 1 1
Crack 1 1
Device Fell 1 1
Device Handling Problem 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1
Inadequate or Insufficient Training 1 1
Component Incompatible 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Insufficient Information 1 1
Muscle/Tendon Damage 1 1
Bruise/Contusion 1 1

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