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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device absorbable collagen hemostatic agent with thrombin
Regulation Description Absorbable hemostatic agent and dressing.
Definition Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Product CodePMX
Regulation Number 878.4490
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
10 5 4 1 3 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2023 5 5
2024 5 5
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Output Problem 1 1
Defective Device 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Fungal Infection 3 3
Insufficient Information 2 2
No Known Impact Or Consequence To Patient 1 1
Seroma 1 1
Thrombosis/Thrombus 1 1
Stenosis 1 1
Nervous System Injury 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-05-2024
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