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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
2019 14 14
2020 3 3
2021 15 15
2022 8 8
2023 7 7
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 16 16
Fracture 11 11
Material Integrity Problem 6 6
Sharp Edges 4 4
Material Fragmentation 3 3
Crack 2 2
Device Fell 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Material Separation 1 1
Component Missing 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 27 27
Insufficient Information 7 7
No Consequences Or Impact To Patient 7 7
No Known Impact Or Consequence To Patient 4 4
Injury 3 3
Foreign Body In Patient 1 1
Laceration(s) 1 1
Tissue Damage 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
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