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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
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

MDR Year MDR Reports MDR Events
2019 297 297
2020 171 171
2021 318 318
2022 159 159
2023 154 154
2024 92 92

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 593 593
Migration 149 149
Break 91 91
Insufficient Information 86 86
Appropriate Term/Code Not Available 82 82
Detachment of Device or Device Component 44 44
Material Protrusion/Extrusion 28 28
Device Appears to Trigger Rejection 23 23
Material Twisted/Bent 23 23
No Apparent Adverse Event 19 19
Positioning Problem 17 17
Material Erosion 15 15
Positioning Failure 15 15
Material Deformation 15 15
Difficult to Advance 11 11
Migration or Expulsion of Device 11 11
Defective Device 10 10
Material Split, Cut or Torn 9 9
Fracture 8 8
Patient-Device Incompatibility 7 7
Premature Activation 7 7
Patient Device Interaction Problem 7 7
Missing Information 6 6
Device Dislodged or Dislocated 6 6
Material Fragmentation 4 4
Material Separation 3 3
Loose or Intermittent Connection 3 3
Difficult or Delayed Separation 3 3
Improper or Incorrect Procedure or Method 2 2
Separation Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Leak/Splash 1 1
Device-Device Incompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Material Too Rigid or Stiff 1 1
Unsealed Device Packaging 1 1
Mechanical Problem 1 1
Malposition of Device 1 1
Disconnection 1 1
Unstable 1 1
Defective Component 1 1
Human-Device Interface Problem 1 1
Difficult to Remove 1 1
Activation, Positioning or Separation Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Deformation Due to Compressive Stress 1 1
Degraded 1 1
Material Frayed 1 1
Difficult or Delayed Positioning 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 480 480
Erosion 347 347
Incontinence 190 190
Injury 168 168
Dyspareunia 152 152
No Clinical Signs, Symptoms or Conditions 142 142
Urinary Incontinence 137 137
Urinary Tract Infection 136 136
Urinary Retention 107 107
Micturition Urgency 103 103
Insufficient Information 101 101
Dysuria 76 76
Unspecified Infection 72 72
No Code Available 69 69
Urinary Frequency 68 68
Scar Tissue 64 64
Abnormal Vaginal Discharge 63 63
Prolapse 62 62
Inflammation 57 57
Not Applicable 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 53 53
Constipation 49 49
Discomfort 49 49
Hematuria 46 46
Abdominal Pain 38 38
No Consequences Or Impact To Patient 36 36
Foreign Body Reaction 34 34
Intermenstrual Bleeding 33 33
Bacterial Infection 29 29
Cramp(s) /Muscle Spasm(s) 29 29
Burning Sensation 28 28
Hemorrhage/Bleeding 27 27
Genital Bleeding 26 26
No Information 24 24
Depression 21 21
Obstruction/Occlusion 21 21
Unspecified Kidney or Urinary Problem 20 20
Perforation 18 18
Nerve Damage 18 18
Muscle Weakness 17 17
Adhesion(s) 16 16
Foreign Body In Patient 16 16
Anxiety 16 16
Skin Erosion 16 16
Unspecified Mental, Emotional or Behavioural Problem 16 16
Nausea 15 15
Fistula 14 14
Fatigue 13 13
Emotional Changes 13 13
Blood Loss 13 13
Deformity/ Disfigurement 13 13
Kidney Infection 13 13
Sexual Dysfunction 13 13
Device Embedded In Tissue or Plaque 12 12
Fever 12 12
Abscess 12 12
Failure of Implant 12 12
Pocket Erosion 12 12
Internal Organ Perforation 11 11
Numbness 11 11
Tissue Damage 10 10
Vomiting 10 10
Hypersensitivity/Allergic reaction 10 10
Itching Sensation 10 10
Swelling/ Edema 10 10
Fecal Incontinence 9 9
Distress 9 9
Fibrosis 9 9
Disability 8 8
Sepsis 8 8
Wound Dehiscence 8 8
Skin Inflammation/ Irritation 8 8
Unspecified Tissue Injury 7 7
Cyst(s) 7 7
Hematoma 7 7
No Known Impact Or Consequence To Patient 7 7
Sleep Dysfunction 7 7
Abdominal Cramps 7 7
Fungal Infection 6 6
Diarrhea 6 6
Anemia 6 6
Neuralgia 6 6
Calcium Deposits/Calcification 5 5
Chest Pain 5 5
Scarring 5 5
Swelling 5 5
Rash 5 5
Myalgia 4 4
Stenosis 4 4
Weight Changes 4 4
Headache 4 4
High Blood Pressure/ Hypertension 4 4
Erythema 4 4
Edema 3 3
Muscle Spasm(s) 3 3
Low Blood Pressure/ Hypotension 3 3
Nervous System Injury 3 3
Lethargy 3 3
Fluid Discharge 3 3
Skin Tears 3 3

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