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	82	82
Break	65	65
Connection Problem	25	25
Crack	25	25
Positioning Problem	11	11
Material Split, Cut or Torn	10	10
Malposition of Device	10	10
Material Puncture/Hole	9	9
Material Fragmentation	8	8
Device Markings/Labelling Problem	5	5
Migration	5	5
Detachment of Device or Device Component	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Obstruction of Flow	5	5
Leak/Splash	4	4
Fracture	4	4
Material Separation	4	4
Defective Device	3	3
Air/Gas in Device	3	3
Complete Blockage	2	2
Difficult to Remove	2	2
Gas/Air Leak	2	2
No Flow	1	1
Inaccurate Information	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
Improper Flow or Infusion	1	1
Component Missing	1	1
Use of Device Problem	1	1
Material Too Rigid or Stiff	1	1
Positioning Failure	1	1
Backflow	1	1
Stretched	1	1
Patient Device Interaction Problem	1	1
Contamination /Decontamination Problem	1	1
Moisture Damage	1	1
Contamination	1	1
Material Integrity Problem	1	1
Unclear Information	1	1
Insufficient Information	1	1
Separation Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	123	123
Foreign Body In Patient	36	36
Insufficient Information	28	28
No Consequences Or Impact To Patient	21	21
Hemorrhage/Bleeding	14	14
Device Embedded In Tissue or Plaque	7	7
Pericardial Effusion	6	6
Blood Loss	5	5
No Known Impact Or Consequence To Patient	5	5
Extravasation	5	5
Abdominal Distention	4	4
Hypoglycemia	4	4
Pleural Effusion	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Death	2	2
Low Blood Pressure/ Hypotension	2	2
Ascites	2	2
Cardiac Tamponade	2	2
Discomfort	2	2
Pain	2	2
Angioedema	1	1
Low Oxygen Saturation	1	1
Bacterial Infection	1	1
Skin Tears	1	1
Swelling/ Edema	1	1
Perforation of Vessels	1	1
Tachycardia	1	1
Renal Failure	1	1
Fluid Discharge	1	1
Bradycardia	1	1
Unspecified Kidney or Urinary Problem	1	1
Cardiogenic Shock	1	1
Septic Shock	1	1
Rash	1	1
Intracranial Hemorrhage	1	1
Respiratory Acidosis	1	1
Malaise	1	1
Peritoneal Laceration(s)	1	1
Hematoma	1	1
No Information	1	1
No Code Available	1	1
Sepsis	1	1
Emotional Changes	1	1
Drug Resistant Bacterial Infection	1	1