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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device light, operating, dental
Product CodeEAZ
Regulation Number 872.4630
Device Class 1

MDR Year MDR Reports MDR Events
2017 11 11
2018 10 10
2019 4 4
2020 3 3
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Component Falling 12 12
Device Fell 9 9
Break 5 5
Installation-Related Problem 5 5
Detachment Of Device Component 4 4
Mechanical Problem 3 3
Misassembly During Maintenance/Repair 2 2
Device Handling Problem 2 2
Defective Device 1 1
Detachment of Device or Device Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Maintenance Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Contusion 5 5
Swelling 5 5
No Known Impact Or Consequence To Patient 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Laceration(s) 4 4
Pain 2 2
Burning Sensation 2 2
No Patient Involvement 2 2
Injury 2 2
Suture Abrasion 1 1
Burn, Thermal 1 1
Abrasion 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Concussion 1 1
No Consequences Or Impact To Patient 1 1
Brain Injury 1 1
Spinal Column Injury 1 1

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