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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
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
2019 1 1
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Improper or Incorrect Procedure or Method 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abscess 1 1
Fever 1 1
Unspecified Infection 1 1
Nerve Damage 1 1
Pain 1 1
Urinary Frequency 1 1
Malaise 1 1
Bowel Perforation 1 1
Dyspareunia 1 1
Insufficient Information 1 1

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