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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apheresis for focal glomerulosclerosis in adult and pediatric patients
Definition Removal of plasma components to treat focal glomerulosclerosis
Product CodePBN
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2021 2 2
2022 2 2
2025 14 14
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 18 18
Insufficient Information 3 3
No Apparent Adverse Event 2 2
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sepsis 4 4
Dyspnea 4 4
Swelling/ Edema 4 4
Abdominal Distention 2 2
Unspecified Kidney or Urinary Problem 2 2
Pulmonary Edema 2 2
Headache 2 2
Ascites 2 2
Low Blood Pressure/ Hypotension 2 2
Urinary Tract Infection 2 2
Nausea 1 1
Diaphoresis 1 1
Presyncope 1 1
Anemia 1 1
Autoimmune Disorder 1 1
Fever 1 1
Chest Pain 1 1
Vomiting 1 1
Numbness 1 1
Renal Impairment 1 1
Renal Failure 1 1
Tachycardia 1 1
Stenosis 1 1
Restenosis 1 1

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