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
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


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOSTONSCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST CORP.
  SUBSTANTIALLY EQUIVALENT 1
MPATHY MEDICAL DEVICES INC
  SUBSTANTIALLY EQUIVALENT 1
NEOMEDIC INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 774 774
2015 679 679
2016 412 412
2017 266 266
2018 392 392
2019 368 368
2020 175 175
2021 647 647
2022 115 115
2023 59 59
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1734 1734
Detachment Of Device Component 419 419
Insufficient Information 341 341
Migration 277 277
Material Erosion 268 268
Appropriate Term/Code Not Available 164 164
Break 154 154
Detachment of Device or Device Component 145 145
Migration or Expulsion of Device 142 142
Extrusion 120 120
Other (for use when an appropriate device code cannot be identified) 77 77
Retraction Problem 42 42
Patient-Device Incompatibility 27 27
Material Protrusion/Extrusion 24 24
Use of Device Problem 17 17
Defective Device 16 16
Patient Device Interaction Problem 14 14
Device Operates Differently Than Expected 13 13
Material Separation 10 10
Torn Material 9 9
Material Split, Cut or Torn 8 8
Positioning Problem 8 8
Malposition of Device 8 8
Material Deformation 7 7
Material Integrity Problem 6 6
Material Twisted/Bent 6 6
Misfire 4 4
Device Or Device Fragments Location Unknown 4 4
Defective Component 3 3
Material Rupture 3 3
Difficult to Remove 3 3
Degraded 3 3
Device Packaging Compromised 3 3
Device-Device Incompatibility 2 2
Missing Value Reason 2 2
Material Disintegration 2 2
Entrapment of Device 2 2
Unexpected Therapeutic Results 2 2
Folded 2 2
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Failure to Fire 1 1
Wrinkled 1 1
Material Perforation 1 1
Device Slipped 1 1
Difficult or Delayed Positioning 1 1
Disconnection 1 1
Calcified 1 1
Component Falling 1 1
Contamination 1 1
Bent 1 1
Device Emits Odor 1 1
Device Appears to Trigger Rejection 1 1
Fire 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Mechanical Problem 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Device Dislodged or Dislocated 1 1
Deformation Due to Compressive Stress 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1624 1625
Erosion 1199 1200
Incontinence 714 714
No Consequences Or Impact To Patient 387 387
Injury 381 381
Unspecified Infection 360 361
Urinary Tract Infection 346 347
Prolapse 288 289
Constipation 261 262
Dyspareunia 257 257
No Code Available 256 256
Death 245 245
Surgical procedure 237 237
No Known Impact Or Consequence To Patient 230 230
Not Applicable 206 206
No Information 203 203
Urinary Retention 203 203
Abnormal Vaginal Discharge 191 191
Insufficient Information 173 173
Device Embedded In Tissue or Plaque 171 171
Urinary Frequency 169 170
Micturition Urgency 158 159
Other (for use when an appropriate patient code cannot be identified) 155 155
Blood Loss 154 154
Hemorrhage/Bleeding 123 123
Discomfort 120 120
Scar Tissue 114 114
Emotional Changes 112 113
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 108 108
Inflammation 104 105
Dysuria 96 97
Unspecified Mental, Emotional or Behavioural Problem 94 94
Scarring 90 90
Abdominal Pain 79 79
Adhesion(s) 70 70
Fistula 64 64
Hematuria 55 56
Disability 54 54
Urinary Incontinence 54 54
Hematoma 54 54
Obstruction/Occlusion 49 49
Bleeding 45 45
Burning Sensation 40 40
Discharge 39 39
Internal Organ Perforation 39 39
Nerve Damage 35 35
Unspecified Tissue Injury 35 35
Neurological Deficit/Dysfunction 29 29
Hernia 28 28
Depression 28 28
Fever 27 27
Perforation 25 25
High Blood Pressure/ Hypertension 24 24
Fatigue 23 23
Abscess 23 23
Anxiety 23 23
Cramp(s) /Muscle Spasm(s) 23 23
Fibrosis 22 22
Nausea 22 22
Sepsis 22 22
Therapeutic Response, Decreased 21 21
Intermenstrual Bleeding 21 21
Sleep Dysfunction 18 18
Numbness 18 18
Treatment with medication(s) 17 17
Bacterial Infection 17 17
Tissue Damage 16 16
Foreign Body In Patient 16 16
Deformity/ Disfigurement 16 16
Cancer 15 15
Itching Sensation 15 15
Cyst(s) 15 15
Diarrhea 15 15
Irritation 13 13
Vomiting 12 12
Swelling 12 12
Anemia 12 12
Fungal Infection 11 11
Complaint, Ill-Defined 10 10
Abdominal Distention 10 10
Swelling/ Edema 10 10
Granuloma 10 10
Pneumonia 10 10
Neuropathy 10 10
Failure of Implant 9 9
Muscle Spasm(s) 9 9
Weakness 9 9
Cardiac Arrest 9 9
Ambulation Difficulties 9 9
Patient Problem/Medical Problem 9 9
Bowel Perforation 8 8
Multiple Organ Failure 8 8
Arthralgia 8 8
Calcium Deposits/Calcification 8 8
Asthma 8 8
Purulent Discharge 8 8
Headache 7 7
Foreign Body Reaction 7 7
Breast Cancer 7 7
Chronic Obstructive Pulmonary Disease (COPD) 7 7

-
-