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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
Definition Call for PMAs 12/30/87 (52 FR 36883 10/1/87))
Product CodeHHS
Regulation Number 884.5380
Device Class 3

MDR Year MDR Reports MDR Events
2019 15085 15085
2020 16135 16135
2021 3725 3725
2022 1640 1640
2023 3637 3637
2024 312 312

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36857 36857
Insufficient Information 6746 6746
Biocompatibility 2942 2942
Device Dislodged or Dislocated 2805 2805
Break 2252 2252
Migration 2069 2069
Expulsion 1279 1279
Appropriate Term/Code Not Available 456 456
Patient-Device Incompatibility 335 335
Patient Device Interaction Problem 270 270
Mechanical Problem 191 191
Material Integrity Problem 122 122
Migration or Expulsion of Device 76 76
Malposition of Device 59 59
Positioning Failure 45 45
Device Damaged by Another Device 36 36
Material Twisted/Bent 29 29
Activation Failure 27 27
Use of Device Problem 21 21
Material Fragmentation 18 18
Positioning Problem 18 18
Difficult to Remove 17 17
Difficult to Insert 13 13
Improper or Incorrect Procedure or Method 12 12
Therapeutic or Diagnostic Output Failure 12 12
Entrapment of Device 11 11
Activation, Positioning or Separation Problem 9 9
Device Handling Problem 8 8
Material Perforation 7 7
Separation Failure 7 7
Defective Device 6 6
Detachment of Device or Device Component 6 6
Material Protrusion/Extrusion 4 4
Failure to Advance 4 4
Off-Label Use 4 4
Product Quality Problem 4 4
Device Appears to Trigger Rejection 3 3
No Pressure 3 3
Output Problem 2 2
Unintended Movement 2 2
No Fail-Safe Mechanism 2 2
Nonstandard Device 2 2
Leak/Splash 2 2
Material Disintegration 2 2
Inaccurate Delivery 2 2
Contamination /Decontamination Problem 1 1
Expiration Date Error 1 1
Defective Component 1 1
Material Rupture 1 1
Unexpected Therapeutic Results 1 1
Unraveled Material 1 1
Burst Container or Vessel 1 1
Corroded 1 1
Fracture 1 1
Premature Activation 1 1
Material Puncture/Hole 1 1
Packaging Problem 1 1
Gas/Air Leak 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 14139 14139
No Code Available 13534 13534
Insufficient Information 4898 4898
Foreign Body In Patient 4467 4467
Uterine Perforation 3640 3640
Device Embedded In Tissue or Plaque 2476 2476
Heavier Menses 2376 2376
Hemorrhage/Bleeding 1879 1879
Abdominal Pain 1812 1812
Pelvic Inflammatory Disease 1258 1258
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1023 1023
No Clinical Signs, Symptoms or Conditions 1001 1001
Perforation 966 966
Genital Bleeding 913 913
Menstrual Irregularities 812 812
Fallopian Tube Perforation 667 667
Menorrhagia 638 638
Hypersensitivity/Allergic reaction 501 501
Ectopic Pregnancy 361 361
Headache 356 356
Fatigue 327 327
Weight Changes 249 249
Hair Loss 216 216
Pregnancy 210 210
Internal Organ Perforation 198 198
Arthralgia 152 152
Pregnancy with a Contraceptive Device 147 147
Rash 145 145
Abdominal Distention 135 135
Depression 131 131
Unspecified Infection 114 114
Nausea 107 107
Anxiety 106 106
Cramp(s) 97 97
Premature Labor 95 95
Urinary Tract Infection 92 92
Bowel Perforation 90 90
Emotional Changes 89 89
Abnormal Vaginal Discharge 84 84
Inflammation 78 78
Abdominal Cramps 75 75
No Information 71 71
Anemia 66 66
Abortion 64 64
Cyst(s) 60 60
Myalgia 59 59
Failure of Implant 57 57
Itching Sensation 57 57
Intermenstrual Bleeding 56 56
No Known Impact Or Consequence To Patient 56 56
Injury 55 55
Discomfort 48 48
Dyspareunia 44 44
Autoimmune Disorder 44 44
Dizziness 43 43
Memory Loss/Impairment 41 41
Complaint, Ill-Defined 39 39
Urticaria 38 38
Swelling 38 38
Sleep Dysfunction 35 35
Death 33 33
Confusion/ Disorientation 32 32
Death, Intrauterine Fetal 31 31
Miscarriage 30 30
Numbness 30 30
Visual Impairment 29 29
Erosion 28 28
Fungal Infection 28 28
Cognitive Changes 28 28
Constipation 25 25
Adhesion(s) 24 24
Blurred Vision 23 23
Unspecified Gastrointestinal Problem 23 23
Vomiting 23 23
Hot Flashes/Flushes 21 21
Sensitivity of Teeth 21 21
Thyroid Problems 21 21
Local Reaction 21 21
Abscess 21 21
Patient Problem/Medical Problem 20 20
Unspecified Reproductive System or Breast Problem 19 19
High Blood Pressure/ Hypertension 19 19
Sepsis 18 18
Reaction 18 18
Autoimmune Reaction 17 17
Incontinence 16 16
Laceration(s) 16 16
Tingling 16 16
Urinary Frequency 16 16
Sweating 15 15
Palpitations 15 15
Cramp(s) /Muscle Spasm(s) 15 15
Vertigo 15 15
Skin Irritation 14 14
Spontaneous Abortion 14 14
Ambulation Difficulties 14 14
Weakness 14 14
Visual Disturbances 13 13
Thrombus 12 12
Fever 12 12

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