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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hemostat
Product CodeHRQ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 9 9
2019 14 14
2020 3 3
2021 15 15
2022 8 8
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 16 16
Fracture 10 10
Material Integrity Problem 6 6
Contamination /Decontamination Problem 5 5
Delivered as Unsterile Product 5 5
Sharp Edges 4 4
Material Fragmentation 3 3
Crack 2 2
Component Missing 2 2
Mechanical Problem 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Material Separation 1 1
Device Fell 1 1
Detachment of Device or Device Component 1 1
Mechanics Altered 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
No Consequences Or Impact To Patient 12 12
Insufficient Information 7 7
No Known Impact Or Consequence To Patient 5 5
Injury 3 3
Foreign Body In Patient 2 2
Laceration(s) 1 1
Mitral Regurgitation 1 1
Tissue Damage 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1

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