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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, laser, photodynamic therapy
Product CodeMVF
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 1 1 0 2 0

MDR Year MDR Reports MDR Events
2021 4 4
2022 2 2
2023 4 4
2024 5 5
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 3 3
Device Appears to Trigger Rejection 2 2
Device Operational Issue 1 1
Output Problem 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Fracture 1 1
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erythema 3 3
Swelling/ Edema 3 3
Caustic/Chemical Burns 3 3
Low Blood Pressure/ Hypotension 3 3
Burning Sensation 2 2
Skin Burning Sensation 2 2
Abdominal Pain 1 1
Syncope/Fainting 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
Dry Eye(s) 1 1
Itching Sensation 1 1
Epistaxis 1 1
Burn(s) 1 1
Fever 1 1
Chills 1 1
Vomiting 1 1
Viral Infection 1 1
Discomfort 1 1
Dyspnea 1 1
Pain 1 1
Stenosis 1 1
Radiation Burn 1 1
Eye Pain 1 1

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