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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 821 821
2025 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4267 4267
Migration 1204 1204
Appropriate Term/Code Not Available 493 493
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
Migration or Expulsion of Device 13 13
Break 13 13
Patient-Device Incompatibility 10 10
Difficult to Advance 10 10
Material Deformation 9 9
Use of Device Problem 9 9
Fracture 9 9
Material Separation 7 7
Difficult to Remove 6 6
Difficult or Delayed Positioning 5 5
Device Dislodged or Dislocated 5 5
Therapeutic or Diagnostic Output Failure 5 5
Unsealed Device Packaging 4 4
Unraveled Material 4 4
Material Disintegration 4 4
No Apparent Adverse Event 4 4
Degraded 4 4
Improper or Incorrect Procedure or Method 3 3
Output Problem 3 3
Contamination 3 3
Device Contaminated During Manufacture or Shipping 3 3
Device Damaged Prior to Use 2 2
Material Fragmentation 2 2
Malposition of Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Delivered as Unsterile Product 2 2
Device Contamination with Chemical or Other Material 2 2
Defective Component 2 2
Missing Information 2 2
Crack 1 1
Unclear Information 1 1
Electromagnetic Compatibility Problem 1 1
Device-Device Incompatibility 1 1
Fluid/Blood Leak 1 1
Calcified 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3190 3190
Erosion 1953 1953
Insufficient Information 1550 1550
Incontinence 1260 1260
Dyspareunia 878 878
Urinary Tract Infection 751 751
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 597 597
Constipation 576 576
Micturition Urgency 498 498
Urinary Retention 483 483
Urinary Incontinence 454 454
Unspecified Infection 407 407
Abnormal Vaginal Discharge 394 394
Hemorrhage/Bleeding 391 391
Urinary Frequency 361 361
Injury 325 325
Inflammation 319 319
Prolapse 311 311
No Code Available 291 291
Scar Tissue 288 288
Unspecified Mental, Emotional or Behavioural Problem 288 288
Discomfort 266 266
Abdominal Pain 247 247
Not Applicable 238 238
Dysuria 226 226
Obstruction/Occlusion 185 185
Unspecified Kidney or Urinary Problem 148 148
Nerve Damage 145 145
Hematuria 138 138
Depression 134 134
Unspecified Tissue Injury 131 131
No Clinical Signs, Symptoms or Conditions 131 131
Adhesion(s) 130 130
Cramp(s) /Muscle Spasm(s) 126 126
Anxiety 120 120
Burning Sensation 115 115
Fatigue 113 113
Numbness 91 91
Ambulation Difficulties 90 90
Bacterial Infection 89 89
Nausea 83 83
Fistula 78 78
Abscess 73 73
Perforation 73 73
Hematoma 72 72
Swelling/ Edema 68 68
Muscle Weakness 65 65
Deformity/ Disfigurement 65 65
Fever 62 62
Diarrhea 57 57

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