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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hemostat
Regulation Description Manual surgical instrument for general use.
Product CodeHRQ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 6 6
2018 9 9
2019 14 14
2020 3 3
2021 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 15 15
Fracture 5 5
Contamination /Decontamination Problem 5 5
Delivered as Unsterile Product 5 5
Sharp Edges 3 3
Material Integrity Problem 3 3
Material Fragmentation 3 3
Component Missing 2 2
Crack 1 1
Mechanical Problem 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 9 9
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 3 3
Injury 3 3
Device Embedded In Tissue or Plaque 2 2
No Code Available 1 1
Needle Stick/Puncture 1 1
Foreign Body In Patient 1 1
Exposure to Body Fluids 1 1
Tissue Damage 1 1
Mitral Regurgitation 1 1

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