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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia
Definition A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Product CodeQKA
Regulation Number 876.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDI-TATE , LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRODEON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2024 5 5
2025 5 5
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Break 3 3
Difficult to Remove 2 2
Defective Component 1 1
Migration 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Tract Infection 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Sepsis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Urinary Incontinence 1 1
Implant Pain 1 1
Insufficient Information 1 1
Urinary Retention 1 1
Micturition Urgency 1 1
Discomfort 1 1
Unspecified Kidney or Urinary Problem 1 1
Renal Impairment 1 1
Urinary Frequency 1 1

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