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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stand, instrument, ac-powered, ophthalmic
Product CodeHMF
Regulation Number 886.1860
Device Class 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 1 1
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 2 2
Insufficient Information 2 2
Power Problem 2 2
Break 1 1
Unintended Electrical Shock 1 1
Thermal Decomposition of Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Electrical Shorting 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Electric Shock 1 1
No Patient Involvement 1 1
Partial thickness (Second Degree) Burn 1 1

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