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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
Regulation Description Surgical mesh.
Definition Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
Product CodeOTO
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2021 292 301
2022 113 118
2023 101 107
2024 113 114
2025 81 81
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 404 421
Migration 134 135
Appropriate Term/Code Not Available 97 97
Material Protrusion/Extrusion 19 19
Device Appears to Trigger Rejection 16 16
Material Erosion 15 15
Material Split, Cut or Torn 10 12
Patient Device Interaction Problem 6 6
Migration or Expulsion of Device 6 6
Break 6 6
Insufficient Information 5 5
Patient-Device Incompatibility 4 4
Defective Device 4 5
Expiration Date Error 3 3
Material Deformation 3 4
Malposition of Device 3 3
Positioning Problem 3 3
Material Integrity Problem 2 2
Stretched 2 2
Fluid/Blood Leak 2 2
Detachment of Device or Device Component 2 2
Therapeutic or Diagnostic Output Failure 1 1
Expulsion 1 1
Material Disintegration 1 1
Device Markings/Labelling Problem 1 1
No Apparent Adverse Event 1 1
Unintended Movement 1 1
Improper or Incorrect Procedure or Method 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Use of Device Problem 1 1
Positioning Failure 1 1
Fracture 1 1
Pressure Problem 1 1
Missing Information 1 1
Material Twisted/Bent 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 385 397
Erosion 305 311
Prolapse 142 149
Urinary Tract Infection 122 125
Dyspareunia 112 116
Urinary Incontinence 108 111
Micturition Urgency 99 103
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 96 97
Unspecified Infection 90 95
Abnormal Vaginal Discharge 90 97
Hemorrhage/Bleeding 87 91
Insufficient Information 79 84
Incontinence 77 84
Urinary Frequency 71 74
Inflammation 69 72
Urinary Retention 62 63
Scar Tissue 61 63
Constipation 57 64
Dysuria 56 57
Adhesion(s) 55 58
Abdominal Pain 49 53
Discomfort 45 48
Cramp(s) /Muscle Spasm(s) 40 41
Hematuria 39 40
Obstruction/Occlusion 36 38
Bacterial Infection 32 33
Nausea 28 28
Fever 27 28
Unspecified Mental, Emotional or Behavioural Problem 26 28
Unspecified Kidney or Urinary Problem 26 26
Burning Sensation 25 26
Deformity/ Disfigurement 25 25
Genital Bleeding 24 24
No Clinical Signs, Symptoms or Conditions 24 27
Intermenstrual Bleeding 24 24
Muscle Weakness 24 26
Abscess 23 26
Depression 21 22
Fistula 20 22
Ambulation Difficulties 19 19
Hernia 19 19
Fecal Incontinence 19 20
Unspecified Tissue Injury 18 18
Diarrhea 17 19
Anxiety 17 20
Hematoma 16 18
Vomiting 16 17
Sexual Dysfunction 15 15
Swelling/ Edema 15 17
Skin Erosion 14 14

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