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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2021 3 3
2022 4 4
2023 7 7
2024 3 3
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Insufficient Information 2 2
Material Integrity Problem 2 2
Appropriate Term/Code Not Available 2 2
Device Slipped 1 1
Material Split, Cut or Torn 1 1
Collapse 1 1
Device Fell 1 1
Defective Device 1 1
Scratched Material 1 1
Degraded 1 1
Fail-Safe Problem 1 1
Detachment of Device or Device Component 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 10 10
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 2 2
Laceration(s) 2 2
Damage to Ligament(s) 1 1
Sleep Dysfunction 1 1
Bone Fracture(s) 1 1
Abrasion 1 1
Spinal Column Injury 1 1
Discomfort 1 1
Pain 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1

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