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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, ventricular
Product CodeHCA
Regulation Number 882.4100
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1
Device Slipped 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cerebrospinal Fluid Leakage 1 1
Failure of Implant 1 1
Cardiac Arrest 1 1
Complaint, Ill-Defined 1 1
Septic Shock 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Abnormal Blood Gases 1 1
Bacterial Infection 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Apr-05-2021
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