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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device scale, stand-on, patient
Product CodeFRI
Regulation Number 880.2700
Device Class 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 3 3
2021 5 5
2022 3 3
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Smoking 7 7
Temperature Problem 3 3
Overheating of Device 2 2
Failure to Power Up 1 1
Product Quality Problem 1 1
Incorrect Measurement 1 1
Melted 1 1
Device Emits Odor 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Material Twisted/Bent 1 1
Power Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 4 4
No Consequences Or Impact To Patient 4 4
Hip Fracture 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Burn(s) 1 1
Fall 1 1

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