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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 3

MDR Year MDR Reports MDR Events
2019 7 7
2020 27 27
2021 9 9
2022 12 12
2023 14 14
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 45 45
Break 29 29
Patient-Device Incompatibility 5 5
Crack 4 4
Device Handling Problem 2 2
Fluid/Blood Leak 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Use of Device Problem 1 1
Material Twisted/Bent 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 26 26
Injury 11 11
No Consequences Or Impact To Patient 10 10
Pericardial Effusion 7 7
Hemorrhage/Bleeding 7 7
Unspecified Infection 4 4
Cardiac Tamponade 4 4
Pseudoaneurysm 4 4
Inflammation 3 3
Fever 3 3
Thrombosis 3 3
Insufficient Information 3 3
Abscess 3 3
Aspiration Pneumonitis 3 3
Post Operative Wound Infection 2 2
Bacterial Infection 2 2
Abdominal Pain 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Wound Dehiscence 1 1
Stroke/CVA 1 1
Infarction, Cerebral 1 1
Pneumothorax 1 1
Ischemia 1 1
Rupture 1 1
No Patient Involvement 1 1
Hemorrhage, Cerebral 1 1
Bradycardia 1 1
Reaction 1 1
Fluid Discharge 1 1
Tachycardia 1 1
Embolism 1 1
Myocardial Infarction 1 1

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