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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
2014 1 1
2015 1 1
2017 1 1
2018 1 1
2020 3 3
2021 1 1
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Power Problem 2 2
Insufficient Information 2 2
Component Falling 2 2
Fire 2 2
Fluid/Blood Leak 1 1
Device Slipped 1 1
Sparking 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Flare or Flash 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Electrical Shock 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
Partial thickness (Second Degree) Burn 1 1
Head Injury 1 1
Tissue Damage 1 1
No Consequences Or Impact To Patient 1 1
Electric Shock 1 1

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