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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device crutch
Product CodeIPR
Regulation Number 890.3150
Device Class 1

MDR Year MDR Reports MDR Events
2014 53 53
2015 12 12
2016 9 9
2017 4 4
2018 4 4
2019 4 4
2020 5 5
2021 3 3
2022 4 4
2023 7 7
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Unstable 10 10
Detachment Of Device Component 5 5
Product Quality Problem 5 5
Collapse 5 5
Disassembly 3 3
Fracture 3 3
Bent 3 3
Device Slipped 3 3
Material Disintegration 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Loose or Intermittent Connection 3 3
Material Integrity Problem 2 2
Device Operates Differently Than Expected 2 2
Appropriate Term/Code Not Available 2 2
Detachment of Device or Device Component 2 2
Crack 2 2
Torn Material 2 2
Split 2 2
Device Fell 2 2
Naturally Worn 2 2
Defective Device 1 1
Defective Component 1 1
Component Falling 1 1
Material Deformation 1 1
Material Separation 1 1
Material Frayed 1 1
Material Split, Cut or Torn 1 1
Insufficient Information 1 1
Degraded 1 1
Material Twisted/Bent 1 1
Out-Of-Box Failure 1 1
Deformation Due to Compressive Stress 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 40 40
Fall 29 29
Injury 12 12
No Clinical Signs, Symptoms or Conditions 5 5
Discomfort 4 4
Laceration(s) 4 4
Bone Fracture(s) 3 3
Damage to Ligament(s) 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
Pain 2 2
Skin Tears 2 2
Sleep Dysfunction 1 1
No Code Available 1 1
Disability 1 1
Head Injury 1 1
Abrasion 1 1
Contusion 1 1
No Patient Involvement 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Loss of consciousness 1 1

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