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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 2

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
Misfire 4 4
Use of Device Problem 4 4
Detachment of Device or Device Component 4 4
Expiration Date Error 3 3
Difficult to Remove 3 3
Patient Device Interaction Problem 3 3
Device Dislodged or Dislocated 3 3
Malposition of Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Labelling, Instructions for Use or Training Problem 2 2
Material Separation 2 2
Loose or Intermittent Connection 2 2
Expulsion 1 1
Mechanical Problem 1 1
Defective Component 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Degraded 1 1
Material Fragmentation 1 1
Mechanics Altered 1 1
Sharp Edges 1 1
Difficult or Delayed Separation 1 1
Failure to Fire 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Fracture 1 1
Appropriate Term/Code Not Available 1 1
Nonstandard Device 1 1
Difficult to Open or Close 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1
Failure to Discharge 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
Cramp(s) 9 9
Hot Flashes/Flushes 9 9
Rash 9 9
Hypersensitivity/Allergic reaction 8 8
No Known Impact Or Consequence To Patient 8 8
Thrombus 8 8
Foreign Body In Patient 8 8
Unspecified Infection 8 8
Sweating 7 7
No Code Available 7 7
Dizziness 7 7
Confusion/ Disorientation 6 6
Dyspnea 6 6
Insufficient Information 6 6
Sleep Dysfunction 6 6
Arthralgia 5 5
Reaction 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Blurred Vision 5 5
Scar Tissue 4 4
Swelling/ Edema 4 4
Burning Sensation 4 4
Dyspareunia 4 4
Abdominal Cramps 4 4
Swelling 4 4
No Consequences Or Impact To Patient 4 4
Constipation 4 4
Tingling 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Device Embedded In Tissue or Plaque 4 4
Patient Problem/Medical Problem 4 4
Adhesion(s) 3 3
Inflammation 3 3

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