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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
2017 1 1
2019 1 1
2020 3 3
2021 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
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
Unspecified Kidney or Urinary Problem 4 4
Swelling/ Edema 2 2
Dehydration 2 2
Chest Pain 2 2
Fever 2 2
High Blood Pressure/ Hypertension 1 1
Tachycardia 1 1
Post Operative Wound Infection 1 1
Cyanosis 1 1
Anemia 1 1
Apheresis 1 1
Dyspnea 1 1

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