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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light, operating, dental
Product CodeEAZ
Regulation Number 872.4630
Device Class 1

MDR Year MDR Reports MDR Events
2018 10 10
2019 4 4
2020 3 3
2021 8 8
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 10 10
Break 4 4
Installation-Related Problem 4 4
Mechanical Problem 3 3
Component Falling 2 2
Misassembly During Maintenance/Repair 2 2
Device Handling Problem 2 2
Device Maintenance Issue 1 1
Detachment Of Device Component 1 1
Detachment of Device or Device Component 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Swelling 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Contusion 3 3
Laceration(s) 2 2
Injury 2 2
Burning Sensation 2 2
Bruise/Contusion 2 2
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
Concussion 1 1
No Consequences Or Impact To Patient 1 1
Neck Pain 1 1
Pain 1 1

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