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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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 32 32
Adverse Event Without Identified Device or Use Problem 8 8
Electrical Shorting 7 7
Sparking 4 4
Optical Problem 3 3
Intermittent Loss of Power 3 3
Temperature Problem 3 3
Smoking 2 2
Device Emits Odor 2 2
Power Problem 2 2
Insufficient Heating 2 2
Connection Problem 2 2
Unexpected Shutdown 1 1
Unintended Electrical Shock 1 1
Intermittent Energy Output 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Ambient Temperature Problem 1 1
Environmental Particulates 1 1
Excessive Heating 1 1
Improper or Incorrect Procedure or Method 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
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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