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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrumentation, surgical mesh, urogynecologic, stress urinary incontinence
Regulation Description Specialized surgical instrumentation for use with urogynecologic surgical mesh.
Definition Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence
Product CodePWJ
Regulation Number 884.4910
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2024 2 2
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Patient-Device Incompatibility 1 1
Therapeutic or Diagnostic Output Failure 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hyperplasia 2 2
Pain 2 2
Unspecified Nervous System Problem 2 2
Sexual Dysfunction 2 2
Swelling/ Edema 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Insufficient Information 1 1
Thrombosis/Thrombus 1 1
Scar Tissue 1 1
Skin Discoloration 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Erythema 1 1
Hemorrhage/Bleeding 1 1

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