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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cable
Product CodeISN
Regulation Number 890.3420
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 4 4
2018 6 6
2019 7 7
2020 4 4
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Delivered as Unsterile Product 6 6
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Energy Output Problem 2 2
Temperature Problem 2 2
Material Fragmentation 1 1
Device Contamination with Body Fluid 1 1
Device Displays Incorrect Message 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
No Patient Involvement 6 6
No Consequences Or Impact To Patient 3 3
Eye Injury 2 2
Pain 1 1
Device Embedded In Tissue or Plaque 1 1

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