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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
Regulation Description Surgical mesh.
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 2

MDR Year MDR Reports MDR Events
2020 1004 1004
2021 2606 2606
2022 809 809
2023 1076 1076
2024 822 822
2025 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4286 4286
Migration 1208 1208
Appropriate Term/Code Not Available 494 494
Insufficient Information 101 101
Positioning Problem 79 79
Material Integrity Problem 53 53
Material Erosion 44 44
Detachment of Device or Device Component 39 39
Material Twisted/Bent 28 28
Material Protrusion/Extrusion 27 27
Patient Device Interaction Problem 22 22
Material Split, Cut or Torn 21 21
Device Appears to Trigger Rejection 18 18
Defective Device 17 17
Break 13 13
Migration or Expulsion of Device 13 13
Difficult to Advance 11 11
Fracture 10 10
Patient-Device Incompatibility 10 10
Material Deformation 9 9
Use of Device Problem 9 9
Material Separation 7 7
Difficult to Remove 6 6
Device Dislodged or Dislocated 5 5
Difficult or Delayed Positioning 5 5
Therapeutic or Diagnostic Output Failure 5 5
No Apparent Adverse Event 4 4
Unraveled Material 4 4
Degraded 4 4
Unsealed Device Packaging 4 4
Material Disintegration 4 4
Contamination 3 3
Output Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Improper or Incorrect Procedure or Method 3 3
Material Fragmentation 2 2
Defective Component 2 2
Delivered as Unsterile Product 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Damaged Prior to Use 2 2
Device Contamination with Chemical or Other Material 2 2
Missing Information 2 2
Malposition of Device 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Obstruction of Flow 1 1
Unclear Information 1 1
Device Markings/Labelling Problem 1 1
Material Rupture 1 1
Electromagnetic Compatibility Problem 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3199 3199
Erosion 1961 1961
Insufficient Information 1552 1552
Incontinence 1264 1264
Dyspareunia 879 879
Urinary Tract Infection 757 757
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 600 600
Constipation 577 577
Micturition Urgency 500 500
Urinary Retention 485 485
Urinary Incontinence 456 456
Unspecified Infection 408 408
Abnormal Vaginal Discharge 395 395
Hemorrhage/Bleeding 392 392
Urinary Frequency 362 362
Injury 325 325
Inflammation 321 321
Prolapse 313 313
No Code Available 291 291
Scar Tissue 289 289
Unspecified Mental, Emotional or Behavioural Problem 289 289
Discomfort 268 268
Abdominal Pain 248 248
Not Applicable 238 238
Dysuria 228 228
Obstruction/Occlusion 185 185
Unspecified Kidney or Urinary Problem 151 151
Nerve Damage 146 146
Hematuria 138 138
Unspecified Tissue Injury 136 136
Depression 135 135
No Clinical Signs, Symptoms or Conditions 132 132
Adhesion(s) 132 132
Cramp(s) /Muscle Spasm(s) 127 127
Anxiety 120 120
Burning Sensation 115 115
Fatigue 113 113
Numbness 91 91
Ambulation Difficulties 91 91
Bacterial Infection 89 89
Nausea 83 83
Fistula 80 80
Perforation 74 74
Abscess 73 73
Hematoma 72 72
Swelling/ Edema 68 68
Deformity/ Disfigurement 65 65
Muscle Weakness 65 65
Fever 62 62
Diarrhea 57 57

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