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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)
2019 2020 2021 2022 2023 2024
0 0 0 1 1 0

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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 3 3
Patient-Device Incompatibility 2 2
Device Operational Issue 1 1
Improper Chemical Reaction 1 1
Output Problem 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 6 6
Low Blood Pressure/ Hypotension 5 5
Pain 4 4
Caustic/Chemical Burns 3 3
Discomfort 3 3
Reaction 2 2
Hypersensitivity/Allergic reaction 2 2
Irritation 2 2
Itching Sensation 1 1
Chills 1 1
Excessive Tear Production 1 1
Scarring 1 1
Skin Irritation 1 1
Swelling 1 1
Blurred Vision 1 1
Vomiting 1 1
Abdominal Pain 1 1
Radiation Burn 1 1
Cataract 1 1
Dry Eye(s) 1 1
Erythema 1 1
Fever 1 1
Hair Loss 1 1
Hemorrhage/Bleeding 1 1
Loss of consciousness 1 1
Confusion/ Disorientation 1 1
Blood Loss 1 1
Partial thickness (Second Degree) Burn 1 1
No Code Available 1 1
Eye Pain 1 1

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