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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 stress urinary incontinence, retropubic or transobturator
Definition Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
Product CodeOTN
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ATHENA SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K211975  Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 Sys ...
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
UROCURE LLC
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 2455 2455
2020 1003 1003
2021 2605 2605
2022 809 809
2023 1076 1076
2024 555 555

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6051 6051
Migration 1540 1540
Appropriate Term/Code Not Available 470 470
Insufficient Information 181 181
Positioning Problem 80 80
Material Erosion 54 54
Material Integrity Problem 51 51
Detachment of Device or Device Component 39 39
Material Protrusion/Extrusion 33 33
Material Twisted/Bent 29 29
Patient-Device Incompatibility 29 29
Material Split, Cut or Torn 23 23
Patient Device Interaction Problem 21 21
Defective Device 20 20
Device Appears to Trigger Rejection 18 18
Migration or Expulsion of Device 15 15
Difficult to Advance 13 13
Material Deformation 12 12
Break 12 12
Material Separation 9 9
Use of Device Problem 9 9
Fracture 8 8
Difficult to Remove 7 7
Therapeutic or Diagnostic Output Failure 7 7
No Apparent Adverse Event 6 6
Device Dislodged or Dislocated 5 5
Unsealed Device Packaging 5 5
Difficult or Delayed Positioning 5 5
Material Disintegration 4 4
Degraded 4 4
Unraveled Material 4 4
Improper or Incorrect Procedure or Method 3 3
Contamination 3 3
Device Contaminated During Manufacture or Shipping 3 3
Output Problem 3 3
Packaging Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Material Fragmentation 2 2
Delivered as Unsterile Product 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Inadequacy of Device Shape and/or Size 2 2
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Obstruction of Flow 1 1
Material Perforation 1 1
Biocompatibility 1 1
Fluid/Blood Leak 1 1
Material Frayed 1 1
Loose or Intermittent Connection 1 1
Crack 1 1
Calcified 1 1
Loss of or Failure to Bond 1 1
Entrapment of Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Electromagnetic Compatibility Problem 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Unclear Information 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3731 3731
Erosion 2342 2342
Insufficient Information 1548 1548
Injury 1509 1509
Incontinence 1484 1484
Not Applicable 1035 1035
Urinary Tract Infection 897 897
Dyspareunia 853 853
Constipation 592 592
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 584 584
Urinary Retention 562 562
Micturition Urgency 534 534
Unspecified Infection 453 453
Urinary Incontinence 422 422
No Code Available 413 413
Urinary Frequency 393 393
Abnormal Vaginal Discharge 388 388
Hemorrhage/Bleeding 384 384
Inflammation 340 340
Prolapse 330 330
Scar Tissue 295 295
Discomfort 289 289
Unspecified Mental, Emotional or Behavioural Problem 275 275
Abdominal Pain 263 263
Dysuria 237 237
Obstruction/Occlusion 219 219
Nerve Damage 160 160
Hematuria 155 155
Adhesion(s) 153 153
Fatigue 144 144
Depression 143 143
Unspecified Kidney or Urinary Problem 134 134
Anxiety 127 127
Unspecified Tissue Injury 123 123
Burning Sensation 120 120
Cramp(s) /Muscle Spasm(s) 119 119
No Clinical Signs, Symptoms or Conditions 108 108
Blood Loss 101 101
Numbness 95 95
Bacterial Infection 93 93
Hematoma 88 88
Ambulation Difficulties 88 88
Abscess 87 87
Nausea 86 86
Perforation 84 84
Fistula 84 84
Disability 74 74
Fever 69 69
Deformity/ Disfigurement 66 66
Swelling/ Edema 65 65
Calcium Deposits/Calcification 63 63
Diarrhea 60 60
Muscle Weakness 58 58
Headache 54 54
Vomiting 51 51
No Consequences Or Impact To Patient 51 51
Itching Sensation 49 49
Hypersensitivity/Allergic reaction 49 49
Sleep Dysfunction 48 48
Fibrosis 47 47
Foreign Body Reaction 45 45
Fecal Incontinence 42 42
Intermenstrual Bleeding 42 42
Genital Bleeding 39 39
Skin Erosion 39 39
Cyst(s) 37 37
Sexual Dysfunction 36 36
No Information 36 36
Hernia 34 34
Scarring 32 32
Rash 31 31
High Blood Pressure/ Hypertension 31 31
Weight Changes 31 31
Foreign Body In Patient 30 30
Skin Inflammation/ Irritation 30 30
Purulent Discharge 30 30
Sepsis 30 30
Pocket Erosion 29 29
Neuropathy 29 29
Internal Organ Perforation 29 29
Wound Dehiscence 29 29
Abdominal Distention 29 29
Emotional Changes 28 28
Chills 28 28
Autoimmune Disorder 27 27
Paresthesia 25 25
Stenosis 24 24
Fungal Infection 24 24
Urethral Stenosis/Stricture 21 21
Anemia 21 21
Dizziness 21 21
Movement Disorder 20 20
Tissue Damage 18 18
Muscle Spasm(s) 16 16
Distress 15 15
Kidney Infection 14 14
Bruise/Contusion 13 13
Low Blood Pressure/ Hypotension 13 13
Failure of Implant 12 12
Flatus 12 12

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