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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 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 33 33
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
Intermittent Loss of Power 3 3
Optical Problem 3 3
Temperature Problem 3 3
Power Problem 2 2
Connection Problem 2 2
Melted 2 2
Insufficient Heating 2 2
Smoking 2 2
Unexpected Shutdown 1 1
Failure to Shut Off 1 1
Unintended Electrical Shock 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Ambient Temperature Problem 1 1
Environmental Particulates 1 1
Device Operates Differently Than Expected 1 1
Excessive Heating 1 1
Light Interference 1 1
Device Inoperable 1 1
Electrical /Electronic Property Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Material Integrity Problem 1 1
Defective Device 1 1
Environmental Compatibility Problem 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
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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