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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
2019 4 4
2020 5 5
2021 3 3
2022 4 4
2023 7 7
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 13 13
Collapse 2 2
Appropriate Term/Code Not Available 2 2
Device Fell 2 2
Material Split, Cut or Torn 1 1
Degraded 1 1
Fracture 1 1
Loose or Intermittent Connection 1 1
Defective Component 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 9 9
No Clinical Signs, Symptoms or Conditions 5 5
Laceration(s) 3 3
Insufficient Information 2 2
Bone Fracture(s) 2 2
Head Injury 1 1
Damage to Ligament(s) 1 1
Pain 1 1
Discomfort 1 1
Injury 1 1
Sleep Dysfunction 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1

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