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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
Regulation Description Surgical mesh.
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
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 4 4
Patient-Device Incompatibility 2 2
Patient Device Interaction Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 5 5
Urinary Tract Infection 3 3
Dyspareunia 3 3
Discomfort 3 3
Abdominal Pain 2 2
Unspecified Infection 2 2
Constipation 2 2
Fatigue 2 2
Erosion 2 2
Urinary Incontinence 2 2
Abnormal Vaginal Discharge 2 2
Prolapse 2 2
Incontinence 2 2
Burning Sensation 2 2
Diarrhea 2 2
Micturition Urgency 2 2
Urinary Retention 2 2
Fibrosis 1 1
Pressure Sores 1 1
Urinary Frequency 1 1
Hemorrhage/Bleeding 1 1
Bacterial Infection 1 1
Swelling/ Edema 1 1
Stenosis 1 1
Dysphagia/ Odynophagia 1 1
Reaction 1 1
Autoimmune Reaction 1 1
Visual Impairment 1 1
Scar Tissue 1 1
Alteration in Body Temperature 1 1
Numbness 1 1
Depression 1 1
Hernia 1 1
Swelling 1 1
Flatus 1 1
Chest Pain 1 1
Foreign Body In Patient 1 1
Chills 1 1
Foreign Body Reaction 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Intermenstrual Bleeding 1 1
Cognitive Changes 1 1
Itching Sensation 1 1
Gastritis 1 1
Asthma 1 1
Anemia 1 1
Ischemia 1 1
Inflammation 1 1
Hematuria 1 1
Necrosis 1 1

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