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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cane
Regulation Description Cane.
Product CodeIPS
Regulation Number 890.3075
Device Class 1

MDR Year MDR Reports MDR Events
2021 11 11
2022 10 10
2023 18 18
2024 5 5
2025 7 7
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 14 14
Material Integrity Problem 6 6
Fracture 6 6
Material Twisted/Bent 5 5
Device Slipped 3 3
Mechanical Problem 3 3
Appropriate Device Problem Term/Code Not Available 3 3
Material Split, Cut or Torn 2 2
Device Damaged Prior to Use 2 2
Unintended Movement 2 2
Material Fragmentation 2 2
Use of Device Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Separation 2 2
No Apparent Adverse Event 2 2
Collapse 1 1
Scratched Material 1 1
Positioning Failure 1 1
Insufficient Device Problem Information 1 1
Sharp Edges 1 1
Environmental Compatibility Problem 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 20 20
No Clinical Signs, Symptoms or Conditions 16 16
Laceration(s) 12 12
Bone Fracture(s) 6 6
Limb Fracture 5 5
Concussion 4 4
Head Injury 3 3
Insufficient Information 3 3
Bruise/Contusion 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Pain 1 1
Vertigo 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Dizziness 1 1
Hip Fracture 1 1
Skin Tears 1 1

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