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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device headlamp, operating, battery-operated
Product CodeHPP
Regulation Number 886.4335
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 2 2
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 3 3
Break 1 1
Material Fragmentation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Use of Device Problem 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Burn(s) 1 1
Erythema 1 1
Pain 1 1
Burn, Thermal 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
Partial thickness (Second Degree) Burn 1 1
Insufficient Information 1 1

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