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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light, surgical, carrier
Product CodeFSZ
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 3 3
2021 3 3
2022 3 3
2023 3 4
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 6 6
Melted 4 4
Break 3 3
Fracture 2 3
Adverse Event Without Identified Device or Use Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Entrapment of Device 1 1
Material Separation 1 1
Smoking 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 9
Superficial (First Degree) Burn 2 2
No Known Impact Or Consequence To Patient 2 2
Breast Discomfort/Pain 2 2
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 1 1
Burn(s) 1 1
Laceration(s) 1 1
Neurological Deficit/Dysfunction 1 1
No Consequences Or Impact To Patient 1 1

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