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TPLC
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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 Code
PAG
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
Material Protrusion/Extrusion
2
2
Migration or Expulsion of Device
2
2
Appropriate Term/Code Not Available
2
2
Patient Device Interaction Problem
1
1
Defective Component
1
1
Break
1
1
Material Erosion
1
1
Fluid/Blood Leak
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
15
15
Incontinence
11
11
Injury
9
9
Urinary Tract Infection
7
7
Unspecified Infection
7
7
Abdominal Pain
7
7
Abnormal Vaginal Discharge
6
6
Discomfort
6
6
Hematuria
6
6
Dysuria
6
6
Urinary Retention
5
5
Erosion
5
5
Inflammation
5
5
Prolapse
5
5
Constipation
4
4
Bacterial Infection
4
4
Urinary Frequency
4
4
Depression
4
4
Fungal Infection
3
3
Blood Loss
3
3
Scarring
3
3
Ossification
3
3
Erythema
3
3
Abscess
3
3
Irritation
3
3
Fever
3
3
Dyspareunia
3
3
Urinary Incontinence
3
3
Micturition Urgency
2
2
Anemia
2
2
Fatigue
2
2
Diarrhea
2
2
Hemorrhage/Bleeding
2
2
Weakness
2
2
Burning Sensation
2
2
Dizziness
2
2
No Consequences Or Impact To Patient
2
2
Discharge
2
2
Disability
2
2
Impaired Healing
1
1
Reaction
1
1
Numbness
1
1
Deformity/ Disfigurement
1
1
Weight Changes
1
1
Intermenstrual Bleeding
1
1
Fluid Discharge
1
1
Foreign Body In Patient
1
1
Fibrosis
1
1
Hernia
1
1
Stenosis
1
1
Pressure Sores
1
1
Visual Impairment
1
1
Chills
1
1
Cramp(s)
1
1
Swelling
1
1
Dysphagia/ Odynophagia
1
1
Ecchymosis
1
1
Emotional Changes
1
1
Apnea
1
1
Asthma
1
1
Autoimmune Reaction
1
1
Chest Pain
1
1
Cyst(s)
1
1
Dehydration
1
1
Gastritis
1
1
Hematoma
1
1
Perforation
1
1
Scar Tissue
1
1
Fistula
1
1
Flatus
1
1
Foreign Body Reaction
1
1
Ischemia
1
1
Itching Sensation
1
1
Nausea
1
1
Necrosis
1
1
Swelling/ Edema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Sleep Dysfunction
1
1
Cognitive Changes
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Alteration in Body Temperature
1
1
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