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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
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)
2018 2019 2020 2021 2022 2023
0 1 2 2 1 0

MDR Year MDR Reports MDR Events
2018 112 112
2019 59 59
2020 47 47
2021 24 24
2022 20 20
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 69 69
Migration or Expulsion of Device 45 45
Patient-Device Incompatibility 44 44
Migration 33 33
Insufficient Information 15 15
Break 10 10
Detachment of Device or Device Component 9 9
Device Dislodged or Dislocated 6 6
Entrapment of Device 6 6
Improper or Incorrect Procedure or Method 5 5
Appropriate Term/Code Not Available 5 5
Device Operates Differently Than Expected 4 4
Misfire 4 4
Use of Device Problem 4 4
Expiration Date Error 3 3
Activation, Positioning or Separation Problem 3 3
Difficult to Remove 3 3
Patient Device Interaction Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Material Separation 2 2
Labelling, Instructions for Use or Training Problem 2 2
Loose or Intermittent Connection 2 2
Detachment Of Device Component 2 2
Malposition of Device 2 2
Premature Activation 2 2
Defective Device 2 2
Device Or Device Fragments Location Unknown 2 2
Failure to Fire 1 1
Device Markings/Labelling Problem 1 1
Expulsion 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Degraded 1 1
Positioning Failure 1 1
Failure to Discharge 1 1
Mechanical Problem 1 1
Fracture 1 1
Material Fragmentation 1 1
Nonstandard Device 1 1
Fitting Problem 1 1
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Difficult to Open or Close 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Firing Problem 1 1
Sharp Edges 1 1
Device Fell 1 1
Difficult or Delayed Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 151 151
Heavier Menses 52 52
Menstrual Irregularities 47 47
Abdominal Pain 46 46
Headache 44 44
Fatigue 34 34
Depression 33 33
Weight Changes 32 32
Anxiety 30 30
Emotional Changes 28 28
Hair Loss 20 20
Hemorrhage/Bleeding 20 20
Abdominal Distention 20 20
Foreign Body In Patient 20 20
Cyst(s) 18 18
Failure of Implant 17 17
Nausea 17 17
No Known Impact Or Consequence To Patient 14 14
Dizziness 13 13
Rash 13 13
Memory Loss/Impairment 12 12
Cramp(s) 12 12
No Code Available 12 12
Hot Flashes/Flushes 11 11
Hypersensitivity/Allergic reaction 11 11
Sweating 10 10
Sleep Dysfunction 9 9
Abdominal Cramps 9 9
Unspecified Infection 9 9
Thrombus 9 9
Burning Sensation 8 8
Laceration(s) 8 8
No Consequences Or Impact To Patient 8 8
Patient Problem/Medical Problem 8 8
Confusion/ Disorientation 7 7
Arthralgia 7 7
Reaction 7 7
Anemia 7 7
Autoimmune Disorder 7 7
Adhesion(s) 6 6
Swelling 6 6
Ambulation Difficulties 6 6
Palpitations 6 6
Constipation 6 6
Pregnancy 5 5
Blood Loss 5 5
Device Embedded In Tissue or Plaque 5 5
Cognitive Changes 5 5
Complaint, Ill-Defined 5 5
Vomiting 5 5
Urinary Tract Infection 5 5
Dyspnea 5 5
Insufficient Information 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Ectopic Pregnancy 4 4
Autoimmune Reaction 4 4
Incontinence 4 4
Blurred Vision 4 4
Itching Sensation 4 4
Scar Tissue 4 4
Discomfort 4 4
Tingling 4 4
Irritability 4 4
Fibrosis 4 4
Injury 4 4
Intermenstrual Bleeding 3 3
Hormonal Imbalance 3 3
Dyspareunia 3 3
Rupture 3 3
Myalgia 3 3
Toxicity 3 3
Malaise 3 3
Thyroid Problems 3 3
Inflammation 3 3
High Blood Pressure/ Hypertension 3 3
Vessel Or Plaque, Device Embedded In 3 3
Arthritis 3 3
Swelling/ Edema 3 3
Unspecified Reproductive System or Breast Problem 3 3
Pregnancy with a Contraceptive Device 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Implant Pain 2 2
Abscess 2 2
Tachycardia 2 2
Sepsis 2 2
Tissue Damage 2 2
Visual Disturbances 2 2
Miscarriage 2 2
Muscle Spasm(s) 2 2
Nerve Damage 2 2
Urticaria 2 2
Inadequate Pain Relief 2 2
Breast Discomfort/Pain 2 2
Convulsion/Seizure 2 2
Syncope/Fainting 2 2
Hematuria 2 2
No Information 2 2
Alteration In Body Temperature 2 2
Dysuria 2 2

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