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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
2018 13 13
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 25 36
Break 4 4
Device-Device Incompatibility 4 4
Smoking 2 2
Fitting Problem 1 1
Material Separation 1 1
Fire 1 1
Fracture 1 3
Leak/Splash 1 1
Electrical Shorting 1 1
Material Deformation 1 1
Material Split, Cut or Torn 1 1
Air Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 27
No Consequences Or Impact To Patient 12 12
No Patient Involvement 4 4
No Known Impact Or Consequence To Patient 3 3
Burn, Thermal 1 1
Burn(s) 1 1

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