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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transcervical contraceptive tubal occlusion device
Regulation Description Contraceptive tubal occlusion device (TOD) and introducer.
Definition Call for PMAs 12/30/87 (52 FR 36883 10/1/87))
Product CodeHHS
Regulation Number 884.5380
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
2 5 1 2 0 0

MDR Year MDR Reports MDR Events
2015 5946 5946
2016 4921 4921
2017 11848 11848
2018 5982 5982
2019 15085 15085
2020 13633 13633

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 42867 42867
Insufficient Information 9932 9932
Patient-Device Incompatibility 4898 4898
Migration 3863 3863
Biocompatibility 3811 3811
Device Dislodged or Dislocated 3738 3738
Break 3545 3545
Migration or Expulsion of Device 2990 2990
Appropriate Term/Code Not Available 1833 1833
Expulsion 1545 1545
Device Operates Differently Than Expected 832 832
Coil 668 668
Malposition of Device 306 306
Difficult to Remove 278 278
Difficult to Insert 271 271
Fracture 158 158
Material Fragmentation 112 112
Unexpected Therapeutic Results 108 108
Entrapment of Device 105 105
Device Appears to Trigger Rejection 101 101
Positioning Failure 92 92
Positioning Problem 91 91
Extrusion 86 86
Therapeutic or Diagnostic Output Failure 85 85
Detachment Of Device Component 83 83
Activation, Positioning or SeparationProblem 80 80
Material Protrusion/Extrusion 79 79
Device Inoperable 78 78
Defective Device 74 74
Bent 74 74
Device Or Device Fragments Location Unknown 71 71
Material Twisted/Bent 69 69
Improper or Incorrect Procedure or Method 64 64
Product Quality Problem 62 62
Separation Failure 57 57
Activation Failure 55 55
Detachment of Device or Device Component 49 49
Difficult or Delayed Positioning 48 48
Device Damaged by Another Device 47 47
Material Perforation 45 45
Catheter 37 37
Sticking 37 37
Component Missing 34 34
Use of Device Problem 32 32
Stretched 28 28
Defective Component 27 27
Material Separation 26 26
Occlusion Within Device 25 25
Tip 22 22
Unraveled Material 20 20
Failure to Advance 15 15
Difficult To Position 15 15
Uncoiled 15 15
Component Falling 14 14
Unintended Movement 13 13
Device Handling Problem 13 13
Metal Shedding Debris 11 11
Material Rupture 11 11
No Pressure 10 10
Premature Activation 10 10
Device Slipped 10 10
Partial Blockage 9 9
Contamination 8 8
Loose or Intermittent Connection 8 8
Misfire 8 8
Tube 8 8
Split 8 8
Retraction Problem 7 7
Device Contamination with Chemical or Other Material 7 7
Material Deformation 7 7
Kinked 7 7
Wire 6 6
Device Deployer 6 6
Spring 6 6
Mechanical Problem 6 6
Physical Property Issue 6 6
Material Disintegration 5 5
Difficult to Advance 5 5
Material Integrity Problem 4 4
Failure to Disconnect 4 4
Physical Resistance/Sticking 4 4
Device Expiration Issue 4 4
Material Puncture/Hole 4 4
Microbial Contamination of Device 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Protective Measures Problem 3 3
Physical Resistance 3 3
Obstruction of Flow 3 3
Structural Problem 3 3
Switch, Push Button 3 3
Device Displays Incorrect Message 3 3
Material Distortion 3 3
Coiled 3 3
Material Erosion 3 3
Leak/Splash 3 3
Material Frayed 3 3
Fail-Safe Design Failure 2 2
Rod 2 2
Failure to Fire 2 2
Chemical Spillage 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 29991 29994
No Code Available 15927 15928
Abdominal Pain 10590 10590
Heavier Menses 10484 10484
Hemorrhage/Bleeding 7903 7903
Foreign Body In Patient 7510 7510
Headache 7486 7486
Uterine Perforation 6528 6529
Fatigue 6353 6354
Menstrual Irregularities 5397 5397
Weight Changes 5294 5295
Hair Loss 4583 4583
Depression 3644 3645
Device Embedded In Tissue or Plaque 3241 3241
Cramp(s) 2801 2801
Rash 2593 2593
Anxiety 2580 2580
Hypersensitivity/Allergic reaction 2514 2514
Abdominal Distention 2373 2373
Abdominal Cramps 2132 2132
Perforation 1972 1972
Arthralgia 1961 1962
Unspecified Infection 1910 1911
Swelling 1811 1811
Emotional Changes 1801 1801
Nausea 1735 1735
Pelvic Inflammatory Disease 1699 1699
Memory Loss/Impairment 1501 1501
Pregnancy 1465 1467
Cyst(s) 1444 1444
Dizziness 1426 1426
Abnormal Vaginal Discharge 1406 1407
Itching Sensation 1165 1166
Complaint, Ill-Defined 1147 1147
Discomfort 1126 1126
Inflammation 1045 1045
Numbness 963 963
Urinary Tract Infection 923 923
Sleep Dysfunction 893 893
Reaction 756 756
Ectopic Pregnancy 746 746
Sweating 743 743
Internal Organ Perforation 688 688
Tissue Damage 668 668
Confusion/ Disorientation 661 661
Flatus 647 647
Tingling 624 624
Disability 609 609
Anemia 600 600
Autoimmune Disorder 593 594
Hot Flashes/Flushes 593 593
Failure of Implant 557 558
Intermenstrual Bleeding 536 536
Blurred Vision 507 507
Muscle Spasm(s) 480 480
No Known Impact Or Consequence To Patient 471 471
Constipation 465 465
Vomiting 451 451
Cognitive Changes 451 451
Injury 440 440
Myalgia 439 439
Visual Impairment 430 430
High Blood Pressure/ Hypertension 414 414
Urticaria 412 412
Palpitations 409 409
Miscarriage 408 409
No Information 402 402
Incontinence 391 391
Burning Sensation 376 377
Ambulation Difficulties 363 363
Fungal Infection 347 347
Thyroid Problems 344 344
Inadequate Pain Relief 338 338
Test Result 328 328
Diarrhea 321 321
Chest Pain 307 307
Bacterial Infection 295 295
Weakness 290 290
Toxicity 266 266
Skin Irritation 251 251
Malaise 249 249
Vertigo 247 247
Dyspnea 239 239
Fever 239 239
Sensitivity of Teeth 231 231
Fibrosis 231 231
Autoimmune Reaction 230 230
Thrombus 221 221
Tinnitus 221 221
Irritability 218 218
Adhesion(s) 215 216
Urinary Frequency 210 210
Arthritis 204 204
Abortion 184 185
Pyrosis/Heartburn 184 184
Bruise/Contusion 178 178
Scarring 168 168
Discharge 162 162
Shaking/Tremors 158 158
Patient Problem/Medical Problem 153 153

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