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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
Regulation Description Operating headlamp.
Product CodeFSR
Regulation Number 886.4335
Device Class 2

MDR Year MDR Reports MDR Events
2020 13 13
2021 14 14
2022 11 11
2023 11 11
2024 15 15
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 39 39
Adverse Event Without Identified Device or Use Problem 7 7
Electrical Shorting 7 7
Sparking 4 4
Intermittent Energy Output 4 4
Optical Problem 3 3
Intermittent Loss of Power 3 3
Temperature Problem 3 3
Smoking 2 2
Battery Problem 2 2
Device Emits Odor 2 2
Power Problem 2 2
Insufficient Heating 2 2
Connection Problem 2 2
Premature Discharge of Battery 2 2
Unexpected Shutdown 1 1
Unintended Electrical Shock 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Defective Component 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
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
Headache 9 9
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 5 5
Pain 2 2
Erythema 1 1
Insufficient Information 1 1

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