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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laparoscopic contraceptive tubal occlusion device
Regulation Description Contraceptive tubal occlusion device (TOD) and introducer.
Definition Call for PMAs to be filed by 12/30/87 (52 FR 36883 (10/1/87))
Product CodeKNH
Regulation Number 884.5380
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
2 1 1 2 0 0

MDR Year MDR Reports MDR Events
2021 24 29
2022 20 20
2023 6 6
2024 9 9
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 15 17
Migration or Expulsion of Device 8 11
Adverse Event Without Identified Device or Use Problem 8 8
Patient-Device Incompatibility 7 8
Insufficient Information 4 4
Entrapment of Device 3 3
Patient Device Interaction Problem 3 3
Expiration Date Error 2 2
Defective Device 2 2
Use of Device Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Break 1 1
Malposition of Device 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Fragmentation 1 1
Misfire 1 1
Mechanics Altered 1 1
Difficult or Delayed Separation 1 1
Material Separation 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 28 30
Menstrual Irregularities 14 14
Failure of Implant 12 13
Abdominal Pain 11 11
Fatigue 9 10
Headache 8 8
Hair Loss 8 8
Weight Changes 7 7
Hemorrhage/Bleeding 7 7
Depression 7 7
Insufficient Information 7 10
Foreign Body In Patient 7 7
Nausea 6 6
Unspecified Infection 5 5
Anxiety 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 5
No Clinical Signs, Symptoms or Conditions 4 4
Dyspareunia 4 4
Unspecified Reproductive System or Breast Problem 3 3
Sexual Dysfunction 3 3
Hormonal Imbalance 3 3
Swelling/ Edema 3 3
Memory Loss/Impairment 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Rash 3 3
Ambulation Difficulties 2 2
Device Embedded In Tissue or Plaque 2 2
Breast Discomfort/Pain 2 2
Arthritis 2 2
Constipation 2 2
Inadequate Pain Relief 2 3
Convulsion/Seizure 2 2
Abscess 2 2
Visual Impairment 2 2
Loss of Range of Motion 2 2
Discomfort 2 3
Unspecified Mental, Emotional or Behavioural Problem 2 2
Autoimmune Disorder 2 2
Sleep Dysfunction 2 3
High Blood Pressure/ Hypertension 2 2
Syncope/Fainting 2 2
Intermenstrual Bleeding 2 2
Cyst(s) 2 2
Dysuria 2 2
Abdominal Distention 2 2
Implant Pain 2 2
Emotional Changes 2 3
Adhesion(s) 2 2
Patient Problem/Medical Problem 1 1
Menorrhagia 1 1

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