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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 3899 3899
2016 1900 1900
2017 675 675
2018 737 737
2019 2455 2455
2020 1003 1003
2021 2605 2605
2022 808 808
2023 1076 1076
2024 483 483

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7699 7699
Appropriate Term/Code Not Available 2517 2517
Migration or Expulsion of Device 1978 1978
Migration 1618 1618
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 41 41
Material Twisted/Bent 40 40
Difficult to Advance 29 29
Detachment Of Device Component 29 29
Material Split, Cut or Torn 28 28
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
Material Frayed 9 9
Hole In Material 8 8
Fracture 8 8
Material Fragmentation 8 8
Degraded 7 7
Unsealed Device Packaging 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
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
Contamination 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
Crack 1 1
Disconnection 1 1
Loss of or Failure to Bond 1 1
Calcified 1 1
Failure To Adhere Or Bond 1 1
Flaked 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 7281 7282
Erosion 5754 5754
No Code Available 4011 4011
Incontinence 2779 2779
Injury 2295 2295
Insufficient Information 1558 1558
Not Applicable 1455 1455
Urinary Tract Infection 1378 1378
Unspecified Infection 1190 1190
Other (for use when an appropriate patient code cannot be identified) 1005 1005
Surgical procedure 980 980
Urinary Retention 915 915
Dyspareunia 850 850
Micturition Urgency 781 781
Urinary Frequency 647 648
Constipation 629 629
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 584 584
Inflammation 496 496
Abnormal Vaginal Discharge 472 472
Prolapse 472 472
No Information 467 467
Scar Tissue 447 447
Hemorrhage/Bleeding 437 438
Urinary Incontinence 418 418
Discomfort 406 406
Blood Loss 366 366
Death 363 363
Dysuria 334 334
Abdominal Pain 325 325
Obstruction/Occlusion 295 295
Hematuria 277 277
Unspecified Mental, Emotional or Behavioural Problem 275 275
Nerve Damage 231 231
Adhesion(s) 229 229
No Consequences Or Impact To Patient 219 219
Emotional Changes 189 189
Fatigue 183 183
Burning Sensation 183 183
Scarring 172 172
Depression 166 166
Ambulation Difficulties 159 159
Fistula 156 156
Anxiety 147 147
Perforation 140 140
Internal Organ Perforation 133 133
Unspecified Kidney or Urinary Problem 127 127
Disability 126 126
Hematoma 125 125
Unspecified Tissue Injury 122 122
Cramp(s) /Muscle Spasm(s) 118 118
Bleeding 117 117
Numbness 111 111
Abscess 109 109
Neurological Deficit/Dysfunction 105 105
Nausea 102 102
Bacterial Infection 102 102
No Clinical Signs, Symptoms or Conditions 100 100
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 68 68
Sleep Dysfunction 67 67
No Known Impact Or Consequence To Patient 67 67
Vomiting 66 66
Cyst(s) 65 65
Swelling/ Edema 65 65
Foreign Body Reaction 62 62
Headache 62 62
Sepsis 62 62
Hernia 61 61
Discharge 60 60
Intermenstrual Bleeding 58 58
Muscle Weakness 57 57
Swelling 56 56
Fibrosis 51 51
Rash 50 50
High Blood Pressure/ Hypertension 49 49
Wound Dehiscence 46 46
Abdominal Distention 45 45
Foreign Body In Patient 44 45
Weight Changes 43 43
Complaint, Ill-Defined 41 41
Fecal Incontinence 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
Stenosis 32 32
Autoimmune Disorder 32 32
Skin Inflammation/ Irritation 32 32
Purulent Discharge 31 31
Therapeutic Response, Decreased 31 31
Chills 31 31
Pocket Erosion 30 30

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