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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filiform and filiform follower
Regulation Description Urethral dilator.
Product CodeFBW
Regulation Number 876.5520
Device Class 1

MDR Year MDR Reports MDR Events
2022 3 3
2023 17 17
2024 3 3
2025 6 6
2026 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Calcified 35 35
Patient Device Interaction Problem 13 13
Fitting Problem 12 12
Device Handling Problem 12 12
Positioning Failure 5 5
Nonstandard Device 5 5
Difficult to Remove 3 3
Material Puncture/Hole 2 2
Difficult to Advance 2 2
Component Missing 2 2
Inflation Problem 2 2
Missing Information 2 2
Inadequate Instructions for Non-Healthcare Professional 1 1
Burst Container or Vessel 1 1
Wrong Label 1 1
Deflation Problem 1 1
Material Fragmentation 1 1
Insufficient Device Problem Information 1 1
Material Rupture 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Component Misassembled 1 1
Inadequate or Insufficient Training 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 70 70
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 14 14
Perforation 4 4
Hematuria 1 1
Bowel Perforation 1 1
Embolism/Embolus 1 1
Foreign Body In Patient 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Tissue Breakdown 1 1

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