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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device stylet, ureteral
Product CodeEYA
Regulation Number 876.5130
Device Class 1

MDR Year MDR Reports MDR Events
2017 7 7
2018 13 13
2019 11 11
2020 8 8
2021 33 33
2022 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged by Another Device 29 29
Unraveled Material 14 14
Break 13 13
Material Fragmentation 6 6
Material Separation 5 5
Material Split, Cut or Torn 5 5
Device Fell 3 3
Material Frayed 3 3
Detachment Of Device Component 3 3
Flaked 2 2
Material Integrity Problem 2 2
Peeled/Delaminated 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Device Markings/Labelling Problem 1 1
Fracture 1 1
Entrapment of Device 1 1
Mechanical Problem 1 1
Uncoiled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32 32
No Consequences Or Impact To Patient 18 18
Foreign Body In Patient 10 10
No Known Impact Or Consequence To Patient 9 9
Device Embedded In Tissue or Plaque 4 4
Injury 2 2
Insufficient Information 2 2
No Patient Involvement 1 1
Tissue Damage 1 1
Uterine Perforation 1 1
No Information 1 1
No Code Available 1 1

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