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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light, headband, surgical
Product CodeFSR
Regulation Number 886.4335
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 13 13
2021 14 14
2022 11 11
2023 11 11
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 20 20
Adverse Event Without Identified Device or Use Problem 8 8
Electrical Shorting 7 7
Sparking 4 4
Temperature Problem 3 3
Intermittent Loss of Power 3 3
Optical Problem 2 2
Smoking 2 2
Device Emits Odor 2 2
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Ambient Temperature Problem 1 1
Connection Problem 1 1
Environmental Particulates 1 1
Material Integrity Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
Headache 10 10
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 5 5
Pain 3 3
Erythema 1 1
Insufficient Information 1 1

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