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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 223 223

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36813 36813
Insufficient Information 6708 6708
Biocompatibility 2905 2905
Device Dislodged or Dislocated 2764 2764
Break 2215 2215
Migration 2032 2032
Expulsion 1277 1277
Appropriate Term/Code Not Available 454 454
Patient-Device Incompatibility 335 335
Patient Device Interaction Problem 270 270
Mechanical Problem 191 191
Material Integrity Problem 121 121
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
Improper or Incorrect Procedure or Method 12 12
Difficult to Insert 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 14079 14079
No Code Available 13534 13534
Insufficient Information 4881 4881
Foreign Body In Patient 4434 4434
Uterine Perforation 3607 3607
Device Embedded In Tissue or Plaque 2467 2467
Heavier Menses 2376 2376
Hemorrhage/Bleeding 1878 1878
Abdominal Pain 1791 1791
Pelvic Inflammatory Disease 1253 1253
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1019 1019
No Clinical Signs, Symptoms or Conditions 1001 1001
Perforation 943 943
Genital Bleeding 893 893
Menstrual Irregularities 806 806
Fallopian Tube Perforation 650 650
Menorrhagia 632 632
Hypersensitivity/Allergic reaction 494 494
Ectopic Pregnancy 361 361
Headache 351 351
Fatigue 326 326
Weight Changes 248 248
Hair Loss 215 215
Pregnancy 210 210
Internal Organ Perforation 175 175
Arthralgia 152 152
Rash 145 145
Pregnancy with a Contraceptive Device 141 141
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
Emotional Changes 89 89
Bowel Perforation 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
Itching Sensation 57 57
No Known Impact Or Consequence To Patient 56 56
Intermenstrual Bleeding 56 56
Injury 55 55
Failure of Implant 53 53
Discomfort 48 48
Autoimmune Disorder 44 44
Dizziness 43 43
Dyspareunia 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
Unspecified Gastrointestinal Problem 23 23
Blurred Vision 23 23
Vomiting 23 23
Hot Flashes/Flushes 21 21
Sensitivity of Teeth 21 21
Abscess 21 21
Thyroid Problems 21 21
Local Reaction 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
Diarrhea 12 12

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