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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 347 347
2020 151 151
2021 290 290
2022 110 110
2023 101 101
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 896 896
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 179 179
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 14 14
Missing Information 12 12
Defective Device 12 12
Device Appears to Trigger Rejection 12 12
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
Corroded 5 5
Detachment of Device or Device Component 5 5
Material Deformation 4 4
Therapeutic or Diagnostic Output Failure 3 3
Malposition of Device 3 3
Stretched 3 3
Reaction 2 2
Defective Component 2 2
Expiration Date Error 2 2
Deformation Due to Compressive Stress 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
Microbial Contamination of Device 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 808 808
Erosion 794 794
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 206 206
No Information 198 198
Prolapse 185 185
Urinary Tract Infection 171 171
Surgical procedure 147 147
Not Applicable 138 138
Micturition Urgency 117 117
Hemorrhage/Bleeding 105 105
Urinary Frequency 100 100
Abnormal Vaginal Discharge 100 100
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 93 93
Abdominal Pain 89 89
Urinary Retention 86 86
Urinary Incontinence 81 81
Dyspareunia 80 80
Scar Tissue 77 77
Inflammation 73 73
Adhesion(s) 69 69
Blood Loss 68 68
Dysuria 68 68
Constipation 63 63
Insufficient Information 60 60
Obstruction/Occlusion 57 57
Fistula 47 47
Discomfort 46 46
Fever 40 40
Internal Organ Perforation 40 40
Hematoma 39 39
Hematuria 38 38
Burning Sensation 35 35
Bacterial Infection 32 32
Abscess 32 32
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 24 24
Death 22 22
Fatigue 22 22
Intermenstrual Bleeding 22 22
Disability 21 21
Genital Bleeding 21 21
Emotional Changes 21 21
Anxiety 21 21
Depression 19 19
Muscle Weakness 18 18
Itching Sensation 18 18
Failure of Implant 17 17
Diarrhea 17 17
Perforation 17 17
Pocket Erosion 17 17
Neurological Deficit/Dysfunction 16 16
Skin Erosion 15 15
Hernia 15 15
Bleeding 15 15
Hypersensitivity/Allergic reaction 15 15
Complaint, Ill-Defined 15 15
No Clinical Signs, Symptoms or Conditions 15 15
Fecal Incontinence 14 14
Vomiting 14 14
Tissue Damage 13 13
Muscle Spasm(s) 13 13
Foreign Body Reaction 13 13
Swelling/ Edema 13 13
Fungal Infection 13 13
Numbness 12 12
Abdominal Distention 12 12
Kidney Infection 12 12
Unspecified Kidney or Urinary Problem 12 12
Wound Dehiscence 12 12
Unspecified Mental, Emotional or Behavioural Problem 11 11
Foreign Body In Patient 10 10
Anemia 10 10
Sepsis 10 10
Swelling 9 9
Perforation of Vessels 9 9
Discharge 9 9
Headache 9 9
Erythema 9 9
Fibrosis 9 9
Weight Changes 9 9
Sexual Dysfunction 9 9
Unspecified Tissue Injury 9 9
Treatment with medication(s) 8 8
Ambulation Difficulties 8 8
Cancer 8 8
No Known Impact Or Consequence To Patient 8 8
Granuloma 8 8
Irritation 8 8
Dizziness 8 8
Rash 7 7
Cyst(s) 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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