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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 stress urinary incontinence, retropubic or transobturator
Definition Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Product CodePAG
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 256 256
2015 73 73
2016 299 299
2017 11 11
2018 4 4
2019 17 17
2020 4 4
2021 5 5
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 466 466
Adverse Event Without Identified Device or Use Problem 155 155
Device Operates Differently Than Expected 18 18
Appropriate Term/Code Not Available 9 9
Unexpected Therapeutic Results 6 6
Patient-Device Incompatibility 4 4
Material Protrusion/Extrusion 3 3
Break 3 3
Material Erosion 2 2
Migration or Expulsion of Device 2 2
Extrusion 1 1
Patient Device Interaction Problem 1 1
Difficult to Remove 1 1
Invalid Sensing 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Fluid/Blood Leak 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 622 622
Injury 602 602
Incontinence 28 28
Erosion 16 16
Unspecified Infection 15 15
Urinary Tract Infection 11 11
No Code Available 11 11
Blood Loss 10 10
Abdominal Pain 9 9
Prolapse 9 9
Urinary Frequency 8 8
Dysuria 8 8
Hematuria 8 8
Scarring 8 8
Discomfort 8 8
Abnormal Vaginal Discharge 7 7
Urinary Retention 7 7
Inflammation 6 6
Bacterial Infection 4 4
Constipation 4 4
Foreign Body In Patient 4 4
Irritation 4 4
Micturition Urgency 4 4
Disability 4 4
Depression 4 4
Ossification 3 3
Fever 3 3
Hernia 3 3
Erythema 3 3
Dyspareunia 3 3
Abscess 3 3
Discharge 3 3
Urinary Incontinence 3 3
Fungal Infection 3 3
Hemorrhage/Bleeding 3 3
Cramp(s) 2 2
Diarrhea 2 2
Burning Sensation 2 2
Weakness 2 2
Fibrosis 2 2
No Consequences Or Impact To Patient 2 2
Anemia 2 2
Complaint, Ill-Defined 2 2
Emotional Changes 2 2
Fatigue 2 2
Malaise 2 2
Dizziness 2 2
Fistula 1 1
Ambulation Difficulties 1 1
Patient Problem/Medical Problem 1 1

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