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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
2014 7 7
2015 19 19
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 16 16
Device Packaging Compromised 7 7
Delivered as Unsterile Product 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Component Missing 6 6
Nonstandard Device 5 5
Unsealed Device Packaging 5 5
Device Operates Differently Than Expected 4 4
Packaging Problem 3 3
Positioning Problem 2 2
Temperature Problem 2 2
Material Integrity Problem 2 2
Energy Output Problem 2 2
Material Fragmentation 2 2
Device Contamination with Body Fluid 1 1
High Readings 1 1
Device Displays Incorrect Message 1 1
Contamination /Decontamination Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 22 22
No Patient Involvement 17 17
No Consequences Or Impact To Patient 7 7
Pain 2 2
Eye Injury 2 2
Muscle Spasm(s) 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1

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