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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
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 808 808
2023 1076 1076
2024 483 483

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6007 6007
Migration 1522 1522
Appropriate Term/Code Not Available 466 466
Insufficient Information 181 181
Positioning Problem 80 80
Material Erosion 54 54
Material Integrity Problem 51 51
Material Protrusion/Extrusion 33 33
Detachment of Device or Device Component 33 33
Patient-Device Incompatibility 29 29
Material Twisted/Bent 28 28
Material Split, Cut or Torn 22 22
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
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
Unsealed Device Packaging 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
Inadequacy of Device Shape and/or Size 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Material Fragmentation 2 2
Delivered as Unsterile Product 2 2
Fluid/Blood Leak 1 1
Material Frayed 1 1
Loose or Intermittent Connection 1 1
Loss of or Failure to Bond 1 1
Entrapment of Device 1 1
Calcified 1 1
Contamination 1 1
Crack 1 1
Obstruction of Flow 1 1
Material Perforation 1 1
Biocompatibility 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 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 3692 3692
Erosion 2312 2312
Insufficient Information 1543 1543
Injury 1509 1509
Incontinence 1471 1471
Not Applicable 1035 1035
Urinary Tract Infection 879 879
Dyspareunia 849 849
Constipation 590 590
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 581 581
Urinary Retention 555 555
Micturition Urgency 522 522
Unspecified Infection 443 443
Urinary Incontinence 415 415
No Code Available 413 413
Abnormal Vaginal Discharge 384 384
Urinary Frequency 383 383
Hemorrhage/Bleeding 380 380
Inflammation 336 336
Prolapse 325 325
Scar Tissue 293 293
Discomfort 284 284
Unspecified Mental, Emotional or Behavioural Problem 275 275
Abdominal Pain 257 257
Dysuria 234 234
Obstruction/Occlusion 218 218
Nerve Damage 160 160
Hematuria 153 153
Adhesion(s) 152 152
Depression 142 142
Fatigue 141 141
Unspecified Kidney or Urinary Problem 127 127
Anxiety 126 126
Unspecified Tissue Injury 119 119
Burning Sensation 117 117
Cramp(s) /Muscle Spasm(s) 115 115
Blood Loss 101 101
No Clinical Signs, Symptoms or Conditions 100 100
Numbness 94 94
Bacterial Infection 92 92
Hematoma 87 87
Ambulation Difficulties 87 87
Nausea 86 86
Abscess 86 86
Perforation 83 83
Fistula 79 79
Disability 74 74
Fever 69 69
Deformity/ Disfigurement 66 66
Swelling/ Edema 64 64
Calcium Deposits/Calcification 63 63
Diarrhea 60 60
Muscle Weakness 56 56
Headache 54 54
Vomiting 51 51
No Consequences Or Impact To Patient 51 51
Itching Sensation 49 49
Hypersensitivity/Allergic reaction 48 48
Fibrosis 47 47
Sleep Dysfunction 47 47
Foreign Body Reaction 44 44
Intermenstrual Bleeding 42 42
Fecal Incontinence 41 41
Genital Bleeding 39 39
Skin Erosion 39 39
Cyst(s) 36 36
Sexual Dysfunction 36 36
No Information 36 36
Hernia 33 33
Scarring 32 32
Rash 31 31
Weight Changes 31 31
Skin Inflammation/ Irritation 30 30
Sepsis 30 30
High Blood Pressure/ Hypertension 30 30
Purulent Discharge 29 29
Wound Dehiscence 29 29
Internal Organ Perforation 29 29
Neuropathy 29 29
Abdominal Distention 29 29
Foreign Body In Patient 29 29
Pocket Erosion 28 28
Chills 28 28
Emotional Changes 28 28
Autoimmune Disorder 26 26
Paresthesia 25 25
Fungal Infection 24 24
Stenosis 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
Flatus 12 12
Post Operative Wound Infection 12 12

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