Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
Regulation Description Surgical mesh for transvaginal pelvic organ prolapse repair.
Definition Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally
Product CodeOTP
Regulation Number 884.5980
Device Class 3

MDR Year MDR Reports MDR Events
2021 647 650
2022 114 115
2023 59 60
2024 36 36
2025 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 602 605
Migration 172 174
Appropriate Term/Code Not Available 89 89
Defective Device 7 7
Positioning Problem 7 7
Patient Device Interaction Problem 7 7
Material Integrity Problem 6 6
Material Twisted/Bent 5 5
Material Erosion 3 3
Material Deformation 2 2
Detachment of Device or Device Component 2 2
Migration or Expulsion of Device 1 1
Malposition of Device 1 1
Insufficient Information 1 1
Difficult or Delayed Positioning 1 1
Material Protrusion/Extrusion 1 1
Calcified 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 616 621
Erosion 373 376
Incontinence 303 305
Dyspareunia 256 258
Constipation 225 225
Insufficient Information 174 176
Abnormal Vaginal Discharge 129 130
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 105 106
Unspecified Mental, Emotional or Behavioural Problem 98 99
Prolapse 90 91
Urinary Tract Infection 86 86
Hemorrhage/Bleeding 72 74
Unspecified Infection 56 57
Urinary Incontinence 53 53
Discomfort 52 53
Micturition Urgency 41 42
Scar Tissue 41 42
Urinary Frequency 39 39
Urinary Retention 36 36
Abdominal Pain 35 36
Unspecified Tissue Injury 34 34
Inflammation 32 32
Adhesion(s) 27 28
Dysuria 24 24
Depression 23 23
Cramp(s) /Muscle Spasm(s) 23 24
Obstruction/Occlusion 23 23
Injury 22 22
Anxiety 18 18
Fistula 18 18
Hematuria 17 17
No Code Available 15 15
Nausea 14 14
Nerve Damage 12 12
High Blood Pressure/ Hypertension 12 12
Unspecified Kidney or Urinary Problem 11 12
Hernia 10 10
Diarrhea 9 9
Fibrosis 9 9
Fever 9 9
Perforation 9 9
Fatigue 8 8
Cyst(s) 8 9
Bacterial Infection 8 8
Burning Sensation 7 7
Bowel Perforation 7 7
Skin Inflammation/ Irritation 7 7
Purulent Discharge 7 7
Hematoma 7 7
Abdominal Distention 7 7

-
-