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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trousers, anti-shock
Regulation Description Compressible limb sleeve.
Product CodeLHX
Regulation Number 870.5800
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 14 14
2023 11 15
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 17 17
Break 7 7
Migration or Expulsion of Device 3 6
Adverse Event Without Identified Device or Use Problem 3 6
Detachment of Device or Device Component 2 2
Mechanical Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 2
Use of Device Problem 1 1
Insufficient Device Problem Information 1 2
Material Deformation 1 1
Material Separation 1 1
Appropriate Device Problem Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
Foreign Body In Patient 6 6
Pain 4 7
Loss of Range of Motion 3 6
Nonunion/Delayed-union Bone Fracture 3 6
Failure of Implant 3 6
Insufficient Information 2 3
Erosion 1 2
Bone Fracture(s) 1 1
Hemorrhage/Blood Loss/Bleeding 1 1

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