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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
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)
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 2 8 11 16 10 5 4 1 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 2 2
2020 1 1
2021 2 2
2023 5 5

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Hematoma 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1
Seroma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-05-2024
2 Baxter Healthcare Corporation II Aug-30-2018
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