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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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Device
light, headband, surgical
Product Code
FSR
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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