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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Product CodeHOI
Regulation Number 886.5840
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Disintegration 1 1
Flaked 1 1
Product Quality Problem 1 1
Failure to Align 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Optical Distortion 1 1
Scratched Material 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Headache 1 1
Irritation 1 1
Nausea 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1

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