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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


Premarket Reviews
ManufacturerDecision
INTEGRA LIFE SCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 4 4
2016 3 3
2017 2 2
2018 1 1
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 23 23
Adverse Event Without Identified Device or Use Problem 9 9
Thermal Decomposition of Device 7 7
Electrical Shorting 7 7
Sparking 5 5
Device Emits Odor 5 5
Temperature Problem 3 3
Intermittent Loss of Power 3 3
Optical Problem 2 2
Melted 2 2
Smoking 2 2
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Electrical /Electronic Property Problem 1 1
Ambient Temperature Problem 1 1
Connection Problem 1 1
Device Operates Differently Than Expected 1 1
Environmental Compatibility Problem 1 1
Environmental Particulates 1 1
Failure to Shut Off 1 1
Light Interference 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
No Known Impact Or Consequence To Patient 19 19
Headache 10 10
No Consequences Or Impact To Patient 8 8
Pain 3 3
Burn(s) 2 2
Erythema 1 1
Insufficient Information 1 1

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