TPLC - Total Product Life Cycle

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Device	agents, embolic, for treatment of uterine fibroids
Regulation Description	Vascular embolization device.
Product Code	NAJ
Regulation Number	870.3300
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	29	29
Defective Device	1	1
Contamination	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	8	8
Necrosis	8	8
Insufficient Information	6	6
Fever	5	5
Hemorrhage/Bleeding	4	4
Abdominal Pain	3	3
Renal Failure	3	3
Fatigue	3	3
Nausea	3	3
No Clinical Signs, Symptoms or Conditions	3	3
Low Blood Pressure/ Hypotension	2	2
Swelling/ Edema	2	2
Heart Failure/Congestive Heart Failure	2	2
Bradycardia	2	2
Urinary Retention	2	2
Vomiting	2	2
Pulmonary Infarction	2	2
Paralysis	2	2
Inflammation	2	2
Unspecified Infection	2	2
Electrolyte Imbalance	1	1
Confusion/ Disorientation	1	1
Thrombosis/Thrombus	1	1
Embolism/Embolus	1	1
Skin Inflammation/ Irritation	1	1
Hematuria	1	1
Sepsis	1	1
Hypersensitivity/Allergic reaction	1	1
Liver Damage/Dysfunction	1	1
Dehydration	1	1
Prolapse	1	1
Menstrual Irregularities	1	1
Skin Infection	1	1
High Blood Pressure/ Hypertension	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Pulmonary Edema	1	1
Unspecified Tissue Injury	1	1
Cerebrospinal Fluid Leakage	1	1
Unspecified Heart Problem	1	1
Weight Changes	1	1
Constipation	1	1
Cardiac Enzyme Elevation	1	1
Sexual Dysfunction	1	1
Loss of Vision	1	1
Ischemia Stroke	1	1
Decreased Appetite	1	1
Pulmonary Embolism	1	1
Fistula	1	1
Urinary Tract Infection	1	1