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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
2014 96 96
2015 22 22
2016 21 21
2017 17 17
2018 13 13
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 76 76
Fracture 28 28
Bent 20 20
Unstable 15 15
Detachment Of Device Component 13 13
Crack 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Material Integrity Problem 7 7
Device Operates Differently Than Expected 7 7
Product Quality Problem 6 6
Collapse 5 5
Material Fragmentation 5 5
Insufficient Information 4 4
Device Slipped 4 4
Material Twisted/Bent 4 4
Use of Device Problem 4 4
Naturally Worn 3 3
Device Damaged Prior to Use 2 2
Appropriate Term/Code Not Available 2 2
Component(s), broken 2 2
Mechanical Problem 2 2
Material Protrusion/Extrusion 2 2
Detachment of Device or Device Component 2 2
Difficult to Fold, Unfold or Collapse 1 1
Unintended Movement 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Component 1 1
Fitting Problem 1 1
Material Split, Cut or Torn 1 1
Device Tipped Over 1 1
Scratched Material 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Sharp Edges 1 1
Environmental Compatibility Problem 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 98 98
Fall 63 63
Laceration(s) 21 21
Bone Fracture(s) 18 18
Bruise/Contusion 11 11
No Known Impact Or Consequence To Patient 8 8
Pain 7 7
No Clinical Signs, Symptoms or Conditions 6 6
Head Injury 5 5
Injury 5 5
Hip Fracture 4 4
Discomfort 3 3
Limb Fracture 3 3
Concussion 2 2
Insufficient Information 2 2
Hemorrhage/Bleeding 2 2
Damage to Ligament(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Disability 1 1
Pulmonary valve replacement 1 1
No Information 1 1
Hematoma 1 1
Rupture 1 1
Blood Loss 1 1
Cellulitis 1 1
Spinal Column Injury 1 1
Nerve Damage 1 1
Eye Injury 1 1
Skin Tears 1 1
Inadequate Pain Relief 1 1

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