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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, laser, fiber optic, photodynamic therapy
Product CodeMVG
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 1 0 0 0 0

MDR Year MDR Reports MDR Events
2020 2 2
2021 2 2
2022 2 2
2023 1 2
2024 3 3
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 13 13
Fracture 2 2
Device Fell 2 2
Material Fragmentation 1 1
Smoking 1 1
Defective Device 1 2
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Integrity Problem 1 1
Melted 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Burn(s) 2 2
Burn, Thermal 1 1
Stenosis 1 1
Gastroesophageal Burn 1 1
Skin Discoloration 1 2
Insufficient Information 1 1
No Known Impact Or Consequence To Patient 1 1
Dyspnea 1 1

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