TPLC - Total Product Life Cycle

• Device: laparoscopic contraceptive tubal occlusion device
• Definition: Call for PMAs to be filed by 12/30/87 (52 FR 36883 (10/1/87))
• Product Code: KNH
• Regulation Number: 884.5380
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
1	2	2	1	1	0

MDR Year	MDR Reports	MDR Events
2019	59	59
2020	47	47
2021	24	24
2022	20	20
2023	6	6
2024	2	2

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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	84	84
Menstrual Irregularities	29	29
Heavier Menses	27	27
Headache	24	24
Fatigue	23	23
Weight Changes	23	23
Depression	21	21
Abdominal Pain	20	20
Hair Loss	17	17
Emotional Changes	16	16
Abdominal Distention	16	16
Failure of Implant	14	14
Anxiety	14	14
Hemorrhage/Bleeding	12	12
Cyst(s)	10	10
Memory Loss/Impairment	10	10
Nausea	9	9
Rash	9	9
Cramp(s)	9	9
Hot Flashes/Flushes	9	9
Thrombus	8	8
Hypersensitivity/Allergic reaction	8	8
Unspecified Infection	8	8
No Known Impact Or Consequence To Patient	8	8
Sweating	7	7
Foreign Body In Patient	7	7
No Code Available	7	7
Dizziness	7	7
Confusion/ Disorientation	6	6
Sleep Dysfunction	6	6
Arthralgia	5	5
Reaction	5	5
Insufficient Information	5	5
No Clinical Signs, Symptoms or Conditions	5	5
Blurred Vision	5	5
Dyspnea	5	5
Swelling	4	4
No Consequences Or Impact To Patient	4	4
Burning Sensation	4	4
Tingling	4	4
Scar Tissue	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Patient Problem/Medical Problem	4	4
Constipation	4	4
Abdominal Cramps	4	4
Device Embedded In Tissue or Plaque	4	4
Palpitations	3	3
Intermenstrual Bleeding	3	3
Blood Loss	3	3
Ambulation Difficulties	3	3
Cognitive Changes	3	3
Irritability	3	3
Malaise	3	3
Breast Discomfort/Pain	3	3
Dyspareunia	3	3
Swelling/ Edema	3	3
Cramp(s) /Muscle Spasm(s)	3	3
Hormonal Imbalance	3	3
Unspecified Reproductive System or Breast Problem	3	3
Incontinence	3	3
Vomiting	3	3
Arthritis	3	3
Adhesion(s)	3	3
Anemia	3	3
Autoimmune Reaction	3	3
Inflammation	3	3
Itching Sensation	3	3
Laceration(s)	3	3
Vessel Or Plaque, Device Embedded In	3	3
High Blood Pressure/ Hypertension	2	2
Abscess	2	2
Autoimmune Disorder	2	2
Tissue Damage	2	2
Urinary Tract Infection	2	2
Discomfort	2	2
Muscle Spasm(s)	2	2
Skin Discoloration	2	2
Pregnancy with a Contraceptive Device	2	2
Implant Pain	2	2
Convulsion/Seizure	2	2
Syncope/Fainting	2	2
Toxicity	2	2
Inadequate Pain Relief	2	2
Urticaria	2	2
Hematuria	2	2
Fibrosis	2	2
Alteration In Body Temperature	2	2
Dysuria	1	1
Fluid Discharge	1	1
No Information	1	1
Shaking/Tremors	1	1
Skin Inflammation	1	1
Injury	1	1
Numbness	1	1
Collapse	1	1
Loss of consciousness	1	1
Unspecified Nervous System Problem	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Swollen Lymph Nodes/Glands	1	1
Thrombosis/Thrombus	1	1