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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drug coated prostatic dilation catheter for benign prostatic hyperplasia
Definition dilate prostatic urethra to treat obstructive urinary symptoms associated with benign prostatic hyperplasia
Product CodeQXB
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 2 1 2 0

MDR Year MDR Reports MDR Events
2024 4 4
2025 3 3
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Device Problem Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hematuria 6 6
Urinary Retention 1 1
Micturition Urgency 1 1
Incontinence 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Inflammation 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Anemia 1 1
Unspecified Tissue Injury 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Urinary Incontinence 1 1

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