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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
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


Premarket Reviews
ManufacturerDecision
COOK BIOTECH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 9 9
2015 10 10
2016 106 106
2018 3 3
2020 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 71 71
Adverse Event Without Identified Device or Use Problem 46 46
Extrusion 4 4
Therapeutic or Diagnostic Output Failure 2 2
Material Protrusion/Extrusion 1 1
Entrapment of Device 1 1
Material Erosion 1 1
Difficult to Insert 1 1
Migration or Expulsion of Device 1 1
Material Puncture/Hole 1 1
Device Slipped 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 119 119
Injury 117 117
Incontinence 4 4
Ambulation Difficulties 3 3
Prolapse 2 2
Erosion 2 2
Fatigue 2 2
Depression 2 2
Abnormal Vaginal Discharge 2 2
Burning Sensation 2 2
Hot Flashes/Flushes 2 2
Urinary Frequency 2 2
Anxiety 2 2
Discomfort 1 1
Inadequate Pain Relief 1 1
Sweating 1 1
Arthralgia 1 1
Micturition Urgency 1 1
Emotional Changes 1 1
Memory Loss/Impairment 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Sleep Dysfunction 1 1
Abdominal Pain 1 1
Cognitive Changes 1 1
Hematuria 1 1
Blood Loss 1 1
Dysuria 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Constipation 1 1
Dyspareunia 1 1

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