TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
HAOLANG MEDICAL USA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	60	60
Break	46	46
Connection Problem	26	26
Material Split, Cut or Torn	10	10
Malposition of Device	9	9
Positioning Problem	9	9
Crack	6	6
Material Puncture/Hole	6	6
Material Fragmentation	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Obstruction of Flow	4	4
Migration	4	4
Air/Gas in Device	3	3
Device Markings/Labelling Problem	2	2
Difficult to Remove	2	2
Material Separation	2	2
Fracture	2	2
Disconnection	1	1
Leak/Splash	1	1
Separation Problem	1	1
Complete Blockage	1	1
Separation Failure	1	1
Contamination	1	1
Stretched	1	1
Positioning Failure	1	1
Gas/Air Leak	1	1
Material Twisted/Bent	1	1
Insufficient Device Problem Information	1	1
Material Perforation	1	1
Illegible Information	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	125	125
Foreign Body In Patient	36	36
Insufficient Information	30	30
Hemorrhage/Blood Loss/Bleeding	13	13
Pericardial Effusion	5	5
Device Embedded In Tissue or Plaque	5	5
Abdominal Distention	4	4
Discomfort	4	4
Extravasation	4	4
Pleural Effusion	3	3
Hypoglycemia	3	3
Ascites	3	3
Low Blood Pressure/ Hypotension	3	3
Cardiac Tamponade	2	2
Pain	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Drug Resistant Bacterial Infection	1	1
Emotional Changes	1	1
Failure of Implant	1	1
Sepsis	1	1
Hematoma	1	1
Peritoneal Laceration(s)	1	1
Malaise	1	1
Respiratory Acidosis	1	1
Intracranial Hemorrhage	1	1
Rash	1	1
Septic Shock	1	1
Cardiogenic Shock	1	1
Unspecified Kidney or Urinary Problem	1	1
Bradycardia	1	1
Elevated ketones/Diabetic Ketoacidosis	1	1
Fluid Discharge	1	1
Perforation of Vessels	1	1
Swelling/ Edema	1	1
Skin Tears	1	1
Bacterial Infection	1	1
Low Oxygen Saturation	1	1
Angioedema	1	1