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	65	65
Break	60	60
Connection Problem	25	25
Crack	11	11
Malposition of Device	10	10
Material Split, Cut or Torn	9	9
Positioning Problem	9	9
Material Puncture/Hole	8	8
Material Fragmentation	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Leak/Splash	4	4
Device Markings/Labelling Problem	4	4
Fracture	4	4
Migration	4	4
Obstruction of Flow	4	4
Defective Device	3	3
Detachment of Device or Device Component	3	3
Material Separation	3	3
Air/Gas in Device	3	3
Difficult to Remove	2	2
Gas/Air Leak	2	2
No Flow	1	1
Human-Device Interface Problem	1	1
Nonstandard Device	1	1
Flushing Problem	1	1
Device Dislodged or Dislocated	1	1
Illegible Information	1	1
Retraction Problem	1	1
Product Quality Problem	1	1
Packaging Problem	1	1
Material Deformation	1	1
Infusion or Flow Problem	1	1
Material Perforation	1	1
Component Missing	1	1
Use of Device Problem	1	1
Positioning Failure	1	1
Stretched	1	1
Contamination /Decontamination Problem	1	1
Contamination	1	1
Material Integrity Problem	1	1
Insufficient Information	1	1
Separation Failure	1	1
Complete Blockage	1	1
Output Problem	1	1
Migration or Expulsion of Device	1	1
Entrapment of Device	1	1
Separation Problem	1	1
Activation, Positioning or Separation Problem	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	122	122
Foreign Body In Patient	35	35
Insufficient Information	26	26
Hemorrhage/Bleeding	13	13
Pericardial Effusion	5	5
Device Embedded In Tissue or Plaque	5	5
Abdominal Distention	4	4
Extravasation	4	4
Pleural Effusion	3	3
Hypoglycemia	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Cardiac Tamponade	2	2
Discomfort	2	2
Pain	2	2
Ascites	2	2
Low Blood Pressure/ Hypotension	2	2
Drug Resistant Bacterial Infection	1	1
Sepsis	1	1
Emotional Changes	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
Fluid Discharge	1	1
Bradycardia	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