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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

MDR Year MDR Reports MDR Events
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
Adverse Event Without Identified Device or Use Problem 16 16
Patient-Device Incompatibility 3 3
Migration or Expulsion of Device 2 2
Material Protrusion/Extrusion 2 2
Appropriate Term/Code Not Available 2 2
Break 1 1
Material Erosion 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 15 15
Incontinence 11 11
Injury 9 9
Abdominal Pain 7 7
Unspecified Infection 7 7
Urinary Tract Infection 7 7
Discomfort 6 6
Dysuria 6 6
Abnormal Vaginal Discharge 6 6
Hematuria 6 6
Erosion 5 5
Prolapse 5 5
Urinary Retention 5 5
Inflammation 5 5
Constipation 4 4
Urinary Frequency 4 4
Bacterial Infection 4 4
Depression 4 4
Scarring 3 3
Blood Loss 3 3
Ossification 3 3
Fever 3 3
Irritation 3 3
Erythema 3 3
Urinary Incontinence 3 3
Abscess 3 3
Fungal Infection 3 3
Dyspareunia 3 3
Disability 2 2
Anemia 2 2
No Consequences Or Impact To Patient 2 2
Hemorrhage/Bleeding 2 2
Dizziness 2 2
Weakness 2 2
Burning Sensation 2 2
Discharge 2 2
Diarrhea 2 2
Micturition Urgency 2 2
Fatigue 2 2
Impaired Healing 1 1
Fistula 1 1
Sleep Dysfunction 1 1
Fibrosis 1 1
Deformity/ Disfigurement 1 1
Pressure Sores 1 1
Weight Changes 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Apnea 1 1
Swelling/ Edema 1 1
Stenosis 1 1

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