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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
Regulation Description Surgical mesh for transvaginal pelvic organ prolapse repair.
Definition Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical and uterine prolapse repair completed transvaginally.
Product CodePAI
Regulation Number 884.5980
Device Class 3

MDR Year MDR Reports MDR Events
2016 106 106
2018 3 3
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 60 60
Adverse Event Without Identified Device or Use Problem 45 45
Material Erosion 1 1
Difficult to Insert 1 1
Material Puncture/Hole 1 1
Patient-Device Incompatibility 1 1
Material Protrusion/Extrusion 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 107 107
Injury 105 105
Burning Sensation 2 2
Hot Flashes/Flushes 2 2
Anxiety 2 2
Depression 2 2
Ambulation Difficulties 2 2
No Known Impact Or Consequence To Patient 1 1
Emotional Changes 1 1
Fatigue 1 1
Memory Loss/Impairment 1 1
Urinary Frequency 1 1
Sweating 1 1
Sleep Dysfunction 1 1
Inadequate Pain Relief 1 1
Constipation 1 1
Arthralgia 1 1
Abdominal Pain 1 1
Incontinence 1 1

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