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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
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


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CALDERA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 3
COLOPLAST CORP.
  SUBSTANTIALLY EQUIVALENT 3
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 267 267
2015 449 449
2016 155 155
2017 75 75
2018 145 145
2019 346 346
2020 151 151
2021 289 289
2022 109 109
2023 99 99
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 888 888
Other (for use when an appropriate device code cannot be identified) 211 211
Material Erosion 209 209
Migration or Expulsion of Device 198 198
Migration 178 178
Appropriate Term/Code Not Available 171 171
Insufficient Information 149 149
Material Protrusion/Extrusion 29 29
Break 23 23
Patient-Device Incompatibility 23 23
Torn Material 17 17
Material Split, Cut or Torn 12 12
Missing Information 12 12
Device Appears to Trigger Rejection 12 12
Defective Device 11 11
Device Operates Differently Than Expected 11 11
Extrusion 10 10
Material Twisted/Bent 7 7
Positioning Problem 6 6
Patient Device Interaction Problem 6 6
Degraded 6 6
Detachment of Device or Device Component 5 5
Corroded 5 5
Material Deformation 4 4
Therapeutic or Diagnostic Output Failure 3 3
Malposition of Device 3 3
Defective Component 2 2
Expiration Date Error 2 2
Deformation Due to Compressive Stress 2 2
Reaction 2 2
Stretched 2 2
Collapse 2 2
Fluid/Blood Leak 2 2
Unsealed Device Packaging 2 2
Material Fragmentation 2 2
Leak/Splash 2 2
Mechanical Problem 2 2
Scratched Material 2 2
Unintended Movement 2 2
Expulsion 2 2
Compatibility Problem 1 1
Material Integrity Problem 1 1
No Apparent Adverse Event 1 1
Noise, Audible 1 1
Pressure Problem 1 1
Physical Resistance/Sticking 1 1
Material Frayed 1 1
Product Quality Problem 1 1
Nonstandard Device 1 1
Fracture 1 1
Device Expiration Issue 1 1
Explanted 1 1
Positioning Failure 1 1
Use of Device Problem 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 804 804
Erosion 788 788
No Code Available 307 307
Other (for use when an appropriate patient code cannot be identified) 248 248
Injury 246 246
Incontinence 226 226
Unspecified Infection 203 203
No Information 198 198
Prolapse 180 180
Urinary Tract Infection 170 170
Surgical procedure 147 147
Not Applicable 138 138
Micturition Urgency 116 116
Hemorrhage/Bleeding 102 102
Urinary Frequency 99 99
Abnormal Vaginal Discharge 97 97
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 92 92
Abdominal Pain 87 87
Urinary Retention 86 86
Urinary Incontinence 79 79
Dyspareunia 78 78
Scar Tissue 75 75
Inflammation 71 71
Dysuria 68 68
Blood Loss 68 68
Adhesion(s) 67 67
Constipation 62 62
Insufficient Information 57 57
Obstruction/Occlusion 55 55
Discomfort 46 46
Fistula 45 45
Internal Organ Perforation 40 40
Fever 39 39
Hematoma 38 38
Hematuria 38 38
Burning Sensation 35 35
Bacterial Infection 32 32
Abscess 30 30
Nerve Damage 30 30
Scarring 28 28
Deformity/ Disfigurement 27 27
Cramp(s) /Muscle Spasm(s) 27 27
Nausea 26 26
No Consequences Or Impact To Patient 23 23
Death 22 22
Fatigue 22 22
Intermenstrual Bleeding 22 22
Disability 21 21
Genital Bleeding 21 21
Emotional Changes 21 21
Anxiety 19 19
Depression 19 19
Itching Sensation 18 18
Failure of Implant 17 17
Diarrhea 17 17
Muscle Weakness 17 17
Perforation 17 17
Pocket Erosion 17 17
Neurological Deficit/Dysfunction 16 16
Skin Erosion 15 15
Complaint, Ill-Defined 15 15
Hernia 15 15
Bleeding 15 15
Hypersensitivity/Allergic reaction 15 15
Vomiting 14 14
No Clinical Signs, Symptoms or Conditions 14 14
Fecal Incontinence 14 14
Fungal Infection 13 13
Tissue Damage 13 13
Muscle Spasm(s) 13 13
Foreign Body Reaction 13 13
Numbness 12 12
Abdominal Distention 12 12
Swelling/ Edema 12 12
Kidney Infection 12 12
Unspecified Kidney or Urinary Problem 12 12
Unspecified Mental, Emotional or Behavioural Problem 11 11
Wound Dehiscence 11 11
Sepsis 10 10
Swelling 9 9
Perforation of Vessels 9 9
Discharge 9 9
Anemia 9 9
Headache 9 9
Erythema 9 9
Foreign Body In Patient 9 9
Fibrosis 9 9
Weight Changes 9 9
Sexual Dysfunction 9 9
Unspecified Tissue Injury 9 9
Treatment with medication(s) 8 8
No Known Impact Or Consequence To Patient 8 8
Cancer 8 8
Ambulation Difficulties 8 8
Granuloma 8 8
Irritation 8 8
Cyst(s) 7 7
Dizziness 7 7
Rash 7 7
Purulent Discharge 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Manufacturing US, LLC II May-20-2013
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