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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sealant, polymerizing
Product CodeNBE
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
2 5 11 3 5 2

MDR Year MDR Reports MDR Events
2019 7 7
2020 27 27
2021 9 9
2022 12 12
2023 14 14
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 38 38
Break 25 25
Crack 3 3
Patient-Device Incompatibility 3 3
Device Handling Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Fluid/Blood Leak 1 1
Material Twisted/Bent 1 1
Improper or Incorrect Procedure or Method 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
Injury 11 11
No Consequences Or Impact To Patient 10 10
Hemorrhage/Bleeding 5 5
Unspecified Infection 4 4
Pseudoaneurysm 4 4
Pericardial Effusion 3 3
Aspiration Pneumonitis 3 3
Insufficient Information 3 3
Inflammation 3 3
Fever 3 3
Thrombosis 3 3
Bacterial Infection 2 2
Post Operative Wound Infection 2 2
No Patient Involvement 1 1
Fluid Discharge 1 1
Reaction 1 1
Bradycardia 1 1
Stroke/CVA 1 1
Infarction, Cerebral 1 1
Embolism 1 1
Hemorrhage, Cerebral 1 1
Wound Dehiscence 1 1
Abdominal Pain 1 1
Abscess 1 1
Rupture 1 1
Ischemia 1 1
Myocardial Infarction 1 1
Pneumothorax 1 1
Tachycardia 1 1

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