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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

MDR Year MDR Reports MDR Events
2021 3725 3730
2022 1640 1640
2023 3637 3637
2024 847 847
2025 755 755
2026 221 221

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8166 8166
Insufficient Information 5115 5115
Biocompatibility 754 754
Break 594 594
Device Dislodged or Dislocated 586 586
Migration 585 585
Appropriate Term/Code Not Available 340 340
Expulsion 287 287
Patient Device Interaction Problem 65 65
Patient-Device Incompatibility 65 67
Entrapment of Device 25 26
Use of Device Problem 23 23
Difficult to Remove 17 17
Improper or Incorrect Procedure or Method 16 16
Lack of Effect 16 16
Material Integrity Problem 15 15
Difficult to Insert 14 14
Positioning Failure 13 13
Migration or Expulsion of Device 12 12
Malposition of Device 8 8
Positioning Problem 6 6
Therapeutic or Diagnostic Output Failure 6 7
Material Fragmentation 6 6
Off-Label Use 6 6
Material Twisted/Bent 4 4
Device Damaged by Another Device 4 4
Output Problem 4 5
Product Quality Problem 3 5
Nonstandard Device 3 3
Activation, Positioning or Separation Problem 3 3
Defective Device 2 2
Material Disintegration 2 2
Activation Failure 2 2
Device Appears to Trigger Rejection 2 2
Unintended Movement 1 1
Expiration Date Error 1 1
Separation Failure 1 1
Device Markings/Labelling Problem 1 1
Material Perforation 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Protrusion/Extrusion 1 1
Separation Problem 1 1
Unexpected Therapeutic Results 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5227 5227
Pain 3228 3232
Abdominal Pain 800 800
Genital Bleeding 647 647
Foreign Body In Patient 566 567
Device Embedded In Tissue or Plaque 552 553
Menorrhagia 528 528
No Clinical Signs, Symptoms or Conditions 442 442
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 437 439
Fallopian Tube Perforation 350 350
Uterine Perforation 336 336
Menstrual Irregularities 313 313
Hypersensitivity/Allergic reaction 261 263
Headache 257 259
Pelvic Inflammatory Disease 218 218
Perforation 195 195
Internal Organ Perforation 173 173
No Code Available 130 130
Abdominal Distention 129 129
Pregnancy with a Contraceptive Device 116 116
Dyspareunia 113 113
Fatigue 94 95
Intermenstrual Bleeding 85 85
Itching Sensation 84 84
Dizziness 78 78
Hemorrhage/Bleeding 74 76
Unspecified Reproductive System or Breast Problem 63 63
Rash 50 52
Ectopic Pregnancy 46 46
Heavier Menses 43 43
Arthralgia 41 42
Weight Changes 40 41
Myalgia 35 35
Abnormal Vaginal Discharge 35 35
Hair Loss 33 35
Intraoperative Pain 30 30
Anemia 28 28
Inflammation 26 27
Urticaria 24 24
Unspecified Infection 24 24
Failure of Implant 23 23
Premature Labor 22 22
Anxiety 22 22
Abdominal Cramps 21 21
Discomfort 19 20
Depression 19 19
Unspecified Gastrointestinal Problem 18 18
Cramp(s) /Muscle Spasm(s) 17 17
Spontaneous Abortion 16 16
Bowel Perforation 14 14

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