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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, retractor, dental
Product CodeEIF
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 8 8
2016 1 1
2017 1 1
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5 5
Component Missing 3 3
Use of Device Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Cut In Material 1 1
Component Falling 1 1
Insufficient Information 1 1
Material Separation 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
No Consequences Or Impact To Patient 4 4
Aspiration/Inhalation 2 2
Injury 2 2
Death 1 1
No Code Available 1 1
Tooth Fracture 1 1
Swelling 1 1
Caustic/Chemical Burns 1 1

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