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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2019 8 8
2020 4 4
2021 11 11
2022 10 10
2023 18 18
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 13 13
Fracture 8 8
Adverse Event Without Identified Device or Use Problem 5 5
Material Integrity Problem 4 4
Material Fragmentation 4 4
Device Slipped 3 3
Material Twisted/Bent 3 3
Use of Device Problem 2 2
Device Damaged Prior to Use 2 2
Appropriate Term/Code Not Available 2 2
Material Split, Cut or Torn 1 1
Sharp Edges 1 1
Scratched Material 1 1
Unintended Movement 1 1
Material Protrusion/Extrusion 1 1
Collapse 1 1
Environmental Compatibility Problem 1 1
Mechanical Problem 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 23 23
Laceration(s) 11 11
Bone Fracture(s) 9 9
No Clinical Signs, Symptoms or Conditions 6 6
Limb Fracture 3 3
Head Injury 3 3
Pain 2 2
Concussion 2 2
Hip Fracture 2 2
Insufficient Information 2 2
Bruise/Contusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Inadequate Pain Relief 1 1
Skin Tears 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1

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