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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spatula, ophthalmic
Product CodeHND
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2016 1 1
2017 3 3
2018 1 1
2019 1 1
2021 4 4
2022 5 5
2023 13 13
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Material Twisted/Bent 3 3
Appropriate Term/Code Not Available 3 3
Material Fragmentation 3 3
Fitting Problem 3 3
Loose or Intermittent Connection 2 2
Material Too Rigid or Stiff 2 2
Difficult to Open or Close 2 2
Detachment Of Device Component 2 2
Fracture 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Device Fell 1 1
Key or Button Unresponsive/not Working 1 1
Use of Device Problem 1 1
Defective Component 1 1
Component Missing 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Difficult to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
Eye Injury 3 3
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 2 2
No Code Available 2 2
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 1 1
Discomfort 1 1
Perforation 1 1
Visual Disturbances 1 1

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