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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
AMERICAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATHENA SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CALDERA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 3
GENERIC MEDICAL DEVICE, INC.
  SUBSTANTIALLY EQUIVALENT 2
GENERIC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MPATHY MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOMEDIC INTERNATIONAL S.L.
  SUBSTANTIALLY EQUIVALENT 1
UROCURE LLC
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 2050 2050
2015 3900 3900
2016 1900 1900
2017 675 675
2018 737 737
2019 2455 2455
2020 1003 1003
2021 2605 2605
2022 809 809
2023 1076 1076
2024 555 555

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7744 7744
Appropriate Term/Code Not Available 2521 2521
Migration or Expulsion of Device 1978 1978
Migration 1636 1636
Insufficient Information 1570 1570
Material Erosion 1104 1104
Other (for use when an appropriate device code cannot be identified) 777 777
Extrusion 152 152
Break 94 94
Positioning Problem 83 83
Device Operates Differently Than Expected 72 72
Patient-Device Incompatibility 69 69
Material Integrity Problem 55 55
Material Protrusion/Extrusion 50 50
Detachment of Device or Device Component 47 47
Material Twisted/Bent 41 41
Difficult to Advance 29 29
Material Split, Cut or Torn 29 29
Detachment Of Device Component 29 29
Material Deformation 25 25
Defective Device 24 24
No Apparent Adverse Event 22 22
Torn Material 22 22
Patient Device Interaction Problem 22 22
Device Appears to Trigger Rejection 19 19
Difficult to Remove 16 16
Malposition of Device 16 16
Material Separation 15 15
Use of Device Problem 11 11
Improper or Incorrect Procedure or Method 11 11
Therapeutic or Diagnostic Output Failure 11 11
Device Dislodged or Dislocated 10 10
Unsealed Device Packaging 9 9
Material Frayed 9 9
Hole In Material 8 8
Fracture 8 8
Material Fragmentation 8 8
Degraded 7 7
Material Perforation 7 7
Separation Failure 7 7
Tear, Rip or Hole in Device Packaging 6 6
Sticking 6 6
Difficult or Delayed Positioning 6 6
Bent 6 6
Device Packaging Compromised 5 5
Folded 4 4
Contamination 4 4
Material Disintegration 4 4
Unraveled Material 4 4
Unknown (for use when the device problem is not known) 4 4
Implant extrusion 4 4
Defective Component 4 4
Material Rupture 4 4
Device Or Device Fragments Location Unknown 3 3
Loose or Intermittent Connection 3 3
Material Puncture/Hole 3 3
Device Contamination with Chemical or Other Material 3 3
Device Contaminated During Manufacture or Shipping 3 3
Output Problem 3 3
Packaging Problem 2 2
Activation, Positioning or Separation Problem 2 2
Scratched Material 2 2
Device Markings/Labelling Problem 2 2
Difficult to Insert 2 2
Delivered as Unsterile Product 2 2
Entrapment of Device 2 2
Explanted 2 2
Fluid/Blood Leak 2 2
Reaction 2 2
Inadequacy of Device Shape and/or Size 2 2
Stretched 2 2
Device Damaged Prior to Use 2 2
Obstruction of Flow 2 2
Cut In Material 1 1
Split 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Device Issue 1 1
Device Displays Incorrect Message 1 1
Biocompatibility 1 1
Connection Problem 1 1
Delamination 1 1
Fitting Problem 1 1
Device Inoperable 1 1
Unstable 1 1
Device Slipped 1 1
Failure To Adhere Or Bond 1 1
Flaked 1 1
Crack 1 1
Disconnection 1 1
Loss of or Failure to Bond 1 1
Calcified 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Kinked 1 1
Leak/Splash 1 1
Product Quality Problem 1 1
Peeled/Delaminated 1 1
Difficult To Position 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 7320 7321
Erosion 5784 5784
No Code Available 4011 4011
Incontinence 2793 2793
Injury 2296 2296
Insufficient Information 1563 1563
Not Applicable 1455 1455
Urinary Tract Infection 1397 1397
Unspecified Infection 1201 1201
Other (for use when an appropriate patient code cannot be identified) 1005 1005
Surgical procedure 980 980
Urinary Retention 923 923
Dyspareunia 854 854
Micturition Urgency 793 793
Urinary Frequency 658 659
Constipation 631 631
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 587 587
Inflammation 500 500
Prolapse 477 477
Abnormal Vaginal Discharge 476 476
No Information 467 467
Scar Tissue 449 449
Hemorrhage/Bleeding 441 442
Urinary Incontinence 425 425
Discomfort 411 411
Blood Loss 366 366
Death 363 363
Dysuria 337 337
Abdominal Pain 331 331
Obstruction/Occlusion 296 296
Hematuria 280 280
Unspecified Mental, Emotional or Behavioural Problem 275 275
Nerve Damage 231 231
Adhesion(s) 230 230
No Consequences Or Impact To Patient 219 219
Emotional Changes 189 189
Fatigue 186 186
Burning Sensation 186 186
Scarring 172 172
Depression 167 167
Fistula 161 161
Ambulation Difficulties 160 160
Anxiety 148 148
Perforation 141 141
Unspecified Kidney or Urinary Problem 134 134
Internal Organ Perforation 133 133
Unspecified Tissue Injury 128 128
Hematoma 126 126
Disability 126 126
Cramp(s) /Muscle Spasm(s) 122 122
Bleeding 117 117
Numbness 112 112
Abscess 110 110
No Clinical Signs, Symptoms or Conditions 108 108
Neurological Deficit/Dysfunction 105 105
Bacterial Infection 103 103
Nausea 102 102
Fever 94 94
Itching Sensation 78 78
Calcium Deposits/Calcification 77 77
Deformity/ Disfigurement 76 76
Treatment with medication(s) 73 73
Diarrhea 69 69
Hypersensitivity/Allergic reaction 69 69
Sleep Dysfunction 68 68
No Known Impact Or Consequence To Patient 67 67
Swelling/ Edema 66 66
Vomiting 66 66
Cyst(s) 66 66
Foreign Body Reaction 63 63
Headache 62 62
Sepsis 62 62
Hernia 62 62
Discharge 60 60
Muscle Weakness 59 59
Intermenstrual Bleeding 58 58
Swelling 56 56
Fibrosis 51 51
Rash 50 50
High Blood Pressure/ Hypertension 50 50
Wound Dehiscence 46 46
Abdominal Distention 45 45
Foreign Body In Patient 45 46
Weight Changes 43 43
Fecal Incontinence 42 42
Complaint, Ill-Defined 41 41
Tissue Damage 40 40
Skin Erosion 39 39
Genital Bleeding 39 39
Neuropathy 38 38
Sexual Dysfunction 37 37
Muscle Spasm(s) 36 36
Fungal Infection 35 35
Autoimmune Disorder 33 33
Purulent Discharge 32 32
Stenosis 32 32
Skin Inflammation/ Irritation 32 32
Therapeutic Response, Decreased 31 31
Chills 31 31
Pocket Erosion 31 31

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems, Inc. II Dec-16-2014
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