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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 266 266

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8121 8121
Insufficient Device Problem Information 5136 5136
Biocompatibility 752 752
Break 591 591
Device Dislodged or Dislocated 585 585
Migration 570 570
Appropriate Device Problem Term/Code Not Available 339 339
Expulsion 286 286
Patient Device Interaction Problem 81 81
Patient-Device Incompatibility 23 23
Entrapment of Device 21 21
Use of Device Problem 20 20
Difficult to Remove 17 17
Material Integrity Problem 16 16
Lack of Effect 16 16
Improper or Incorrect Procedure or Method 16 16
Difficult to Insert 15 15
Positioning Failure 12 12
Malposition of Device 7 7
Off-Label Use 6 6
Positioning Problem 6 6
Material Fragmentation 5 5
Material Twisted/Bent 4 4
Device Damaged by Another Device 4 4
Activation, Positioning or Separation Problem 3 3
Material Protrusion/Extrusion 3 3
Material Disintegration 2 2
Defective Device 2 2
Activation Failure 2 2
Migration or Expulsion of Device 1 1
Device Markings/Labelling Problem 1 1
Separation Failure 1 1
Expiration Date Error 1 1
Use of Incorrect Control/Treatment Settings 1 1
Nonstandard Device 1 1
Device Appears to Trigger Rejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5252 5252
Pain 3244 3248
Abdominal Pain 821 821
Genital Bleeding 652 652
Foreign Body In Patient 568 569
Device Embedded In Tissue or Plaque 556 557
Menorrhagia 542 542
Pelvic Pain 477 477
No Clinical Signs, Symptoms or Conditions 442 442
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 437 439
Fallopian Tube Perforation 351 351
Uterine Perforation 336 336
Menstrual Irregularities 323 323
Headache 272 274
Hypersensitivity/Allergic reaction 267 269
Pelvic Inflammatory Disease 219 219
Perforation 195 195
Internal Organ Perforation 176 176
Abdominal Distention 137 137
No Code Available 130 130
Dyspareunia 121 121
Pregnancy with a Contraceptive Device 117 117
Fatigue 94 95
Intermenstrual Bleeding 92 92
Itching Sensation 89 89
Dizziness 86 86
Hemorrhage/Blood Loss/Bleeding 76 78
Unspecified Reproductive System or Breast Problem 64 64
Rash 52 54
Ectopic Pregnancy 46 46
Heavier Menses 43 43
Arthralgia 41 42
Weight Changes 41 42
Abnormal Vaginal Discharge 37 37
Myalgia 35 35
Hair Loss 33 35
Intraoperative Pain 32 32
Anemia 29 29
Inflammation 27 28
Failure of Implant 26 26
Urticaria 25 25
Unspecified Infection 25 25
Abdominal Cramps 22 22
Anxiety 22 22
Premature Labor 22 22
Discomfort 20 21
Depression 19 19
Unspecified Gastrointestinal Problem 18 18
Cramp(s) /Muscle Spasm(s) 17 17
Spontaneous Abortion 16 16

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