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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, female, mini-sling
Regulation Description Surgical mesh.
Definition Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Product CodePAH
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 170 170
2021 318 318
2022 159 159
2023 154 154
2024 287 287
2025 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 475 475
Break 196 196
Migration 125 125
Appropriate Term/Code Not Available 84 84
Detachment of Device or Device Component 46 46
Device Dislodged or Dislocated 36 36
Insufficient Information 34 34
Device Appears to Trigger Rejection 25 25
Material Split, Cut or Torn 22 22
Material Protrusion/Extrusion 21 21
No Apparent Adverse Event 19 19
Material Twisted/Bent 19 19
Positioning Problem 17 17
Material Erosion 14 14
Material Deformation 14 14
Material Fragmentation 13 13
Migration or Expulsion of Device 10 10
Difficult to Advance 9 9
Defective Device 9 9
Patient Device Interaction Problem 9 9
Positioning Failure 9 9
Fracture 8 8
Material Separation 8 8
Malposition of Device 7 7
Premature Activation 6 6
Improper or Incorrect Procedure or Method 6 6
Material Frayed 5 5
Missing Information 5 5
Device Slipped 4 4
Difficult or Delayed Separation 3 3
Loose or Intermittent Connection 2 2
Unintended System Motion 2 2
Inadequacy of Device Shape and/or Size 2 2
Patient-Device Incompatibility 2 2
Separation Problem 2 2
Difficult or Delayed Positioning 1 1
Delivered as Unsterile Product 1 1
Material Too Rigid or Stiff 1 1
Degraded 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Difficult to Remove 1 1
Deflation Problem 1 1
Product Quality Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Activation Failure 1 1
Defective Component 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 430 430
Erosion 346 346
No Clinical Signs, Symptoms or Conditions 330 330
Dyspareunia 177 177
Urinary Incontinence 170 170
Urinary Tract Infection 143 143
Incontinence 138 138
Micturition Urgency 112 112
Urinary Retention 110 110
Insufficient Information 100 100
Abnormal Vaginal Discharge 84 84
Dysuria 80 80
Unspecified Infection 76 76
Urinary Frequency 76 76
Scar Tissue 65 65
Prolapse 61 61
Inflammation 59 59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 56 56
Constipation 51 51
Hematuria 51 51
Discomfort 48 48
No Code Available 47 47
Hemorrhage/Bleeding 44 44
Abdominal Pain 38 38
Injury 36 36
Cramp(s) /Muscle Spasm(s) 35 35
Bacterial Infection 29 29
Burning Sensation 29 29
Intermenstrual Bleeding 28 28
Genital Bleeding 27 27
Unspecified Kidney or Urinary Problem 24 24
Foreign Body In Patient 23 23
Deformity/ Disfigurement 22 22
Muscle Weakness 21 21
Foreign Body Reaction 21 21
Unspecified Mental, Emotional or Behavioural Problem 21 21
Depression 21 21
Perforation 20 20
Obstruction/Occlusion 20 20
Nerve Damage 19 19
Sexual Dysfunction 18 18
No Consequences Or Impact To Patient 17 17
Fistula 17 17
Anxiety 16 16
Skin Erosion 16 16
Nausea 16 16
Impaired Healing 15 15
Abscess 14 14
Emotional Changes 14 14
Kidney Infection 14 14

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