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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)
2019 2020 2021 2022 2023 2024
1 2 2 1 1 1

MDR Year MDR Reports MDR Events
2019 59 59
2020 47 47
2021 24 24
2022 20 20
2023 6 6
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 38 38
Migration or Expulsion of Device 27 27
Patient-Device Incompatibility 27 27
Migration 25 25
Break 9 9
Entrapment of Device 5 5
Insufficient Information 5 5
Use of Device Problem 4 4
Misfire 4 4
Detachment of Device or Device Component 4 4
Expiration Date Error 3 3
Device Dislodged or Dislocated 3 3
Patient Device Interaction Problem 3 3
Difficult to Remove 3 3
Malposition of Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Loose or Intermittent Connection 2 2
Labelling, Instructions for Use or Training Problem 2 2
Material Separation 2 2
Mechanical Problem 1 1
Defective Component 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Difficult or Delayed Separation 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1
Material Fragmentation 1 1
Degraded 1 1
Fracture 1 1
Appropriate Term/Code Not Available 1 1
Nonstandard Device 1 1
Difficult to Open or Close 1 1
Failure to Discharge 1 1
Expulsion 1 1
Mechanics Altered 1 1
Sharp Edges 1 1
Material Protrusion/Extrusion 1 1
Failure to Fire 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 86 86
Menstrual Irregularities 30 30
Heavier Menses 27 27
Headache 25 25
Weight Changes 24 24
Fatigue 24 24
Abdominal Pain 23 23
Depression 21 21
Hair Loss 18 18
Failure of Implant 17 17
Abdominal Distention 16 16
Emotional Changes 16 16
Anxiety 14 14
Hemorrhage/Bleeding 13 13
Cyst(s) 10 10
Memory Loss/Impairment 10 10
Nausea 10 10
Rash 9 9
Cramp(s) 9 9
Hot Flashes/Flushes 9 9
Hypersensitivity/Allergic reaction 8 8
Foreign Body In Patient 8 8
Unspecified Infection 8 8
No Known Impact Or Consequence To Patient 8 8
Thrombus 8 8
Sweating 7 7
No Code Available 7 7
Dizziness 7 7
Dyspnea 6 6
Insufficient Information 6 6
Sleep Dysfunction 6 6
Confusion/ Disorientation 6 6
Reaction 5 5
Arthralgia 5 5
Blurred Vision 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Scar Tissue 4 4
Swelling/ Edema 4 4
Dyspareunia 4 4
Swelling 4 4
Constipation 4 4
No Consequences Or Impact To Patient 4 4
Burning Sensation 4 4
Device Embedded In Tissue or Plaque 4 4
Abdominal Cramps 4 4
Tingling 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Patient Problem/Medical Problem 4 4
Adhesion(s) 3 3
Malaise 3 3

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