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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, for stress urinary incontinence, male
Regulation Description Surgical mesh.
Definition surgical treatment of male stress urinary incontinence post-prostatectomy
Product CodeOTM
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
COLOPLAST
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2021 213 213
2022 199 200
2023 28 28
2024 43 44
2025 47 47
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Device Problem Information 334 335
Adverse Event Without Identified Device or Use Problem 132 133
Mechanical Problem 30 30
Break 11 11
Defective Device 11 11
Malposition of Device 7 7
Material Split, Cut or Torn 3 3
Improper or Incorrect Procedure or Method 2 2
Packaging Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Dislodged or Dislocated 2 2
Device Damaged Prior to Use 2 2
Device Contamination with Chemical or Other Material 2 2
Contamination /Decontamination Problem 1 1
Stretched 1 1
Migration 1 1
Material Frayed 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Difficult to Remove 1 1
Expiration Date Error 1 1
Component Missing 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 223 224
Urinary Incontinence 219 220
Insufficient Information 58 58
Incontinence 15 16
Pain 15 15
Urinary Retention 14 14
No Known Impact Or Consequence To Patient 13 13
Erosion 6 6
Discomfort 5 5
Micturition Urgency 4 4
Unspecified Infection 4 4
Urinary Tract Infection 4 4
Numbness 3 3
Hematoma 3 3
Foreign Body In Patient 2 2
Wound Dehiscence 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Swelling/ Edema 2 2
Scar Tissue 1 1
Tactile Disorders 1 1
Inflammation 1 1
Urinary Frequency / Polyuria 1 1
Sepsis 1 1
Abscess 1 1
Unspecified Tissue Injury 1 1
Ecchymosis 1 1
Burning Sensation 1 1
Perforation 1 1
Perforation of Vessels 1 1
Skin Inflammation/ Irritation 1 1
Post Operative Wound Infection 1 1

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