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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device helmet, surgical
Product CodeFXZ
Regulation Number 878.4040
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 4 4
2021 4 15
2022 4 4
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 15 26
Device-Device Incompatibility 4 4
Break 3 3
Fracture 1 3
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 27
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 1 1
Burn(s) 1 1
No Consequences Or Impact To Patient 1 1
Burn, Thermal 1 1

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