TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT - KIT	2
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT - KIT	4
	SUBSTANTIALLY EQUIVALENT	1
YOUCARE TECHNOLOGY CO., LTD. (WUHAN)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	70	70
Adverse Event Without Identified Device or Use Problem	60	60
Fluid/Blood Leak	27	27
Break	24	24
Material Rupture	20	20
Fracture	19	19
Difficult to Remove	18	18
Material Separation	15	15
Leak/Splash	13	13
Material Deformation	13	13
Difficult to Advance	13	13
Material Split, Cut or Torn	12	12
Device Contamination with Chemical or Other Material	10	10
Inflation Problem	10	10
Material Puncture/Hole	10	10
Detachment of Device or Device Component	9	9
Material Fragmentation	7	7
Use of Device Problem	7	7
Material Integrity Problem	5	5
Nonstandard Device	5	5
Obstruction of Flow	5	5
Material Twisted/Bent	5	5
Defective Device	4	4
Stretched	4	4
Deflation Problem	3	3
Crack	3	3
Appropriate Term/Code Not Available	3	3
Device Contaminated During Manufacture or Shipping	3	3
Entrapment of Device	3	3
Complete Blockage	2	2
Separation Failure	2	2
Mechanical Jam	2	2
Unsealed Device Packaging	2	2
Deformation Due to Compressive Stress	2	2
Difficult to Insert	2	2
Positioning Failure	2	2
Component Missing	2	2
Physical Resistance/Sticking	2	2
Difficult to Open or Remove Packaging Material	2	2
Device Handling Problem	2	2
Product Quality Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Fitting Problem	1	1
No Flow	1	1
Difficult to Open or Close	1	1
Component Incompatible	1	1
Connection Problem	1	1
Device Dislodged or Dislocated	1	1
Failure to Advance	1	1
Failure to Infuse	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	160	160
No Consequences Or Impact To Patient	69	69
No Known Impact Or Consequence To Patient	50	50
No Code Available	18	18
Hemorrhage/Bleeding	17	17
Sepsis	13	13
Insufficient Information	11	11
Obstruction/Occlusion	10	10
Renal Failure	7	7
Urinary Tract Infection	6	6
Foreign Body In Patient	6	6
No Patient Involvement	6	6
Septic Shock	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hematuria	4	4
Perforation	4	4
Pain	4	4
Device Embedded In Tissue or Plaque	3	3
Pseudoaneurysm	3	3
Pneumothorax	2	2
Failure of Implant	2	2
Respiratory Failure	2	2
Hematoma	2	2
Post Operative Wound Infection	2	2
Fever	2	2
Pleural Effusion	2	2
Abscess	2	2
Pneumonia	2	2
Fistula	1	1
Pulmonary Embolism	1	1
Internal Organ Perforation	1	1
Hemothorax	1	1
Respiratory Insufficiency	1	1
Unspecified Tissue Injury	1	1
Anxiety	1	1
Perforation of Vessels	1	1
Fluid Discharge	1	1
Unspecified Kidney or Urinary Problem	1	1
Urinary Retention	1	1
Transient Ischemic Attack	1	1
Deposits	1	1
Cardiac Arrest	1	1
Purulent Discharge	1	1
No Information	1	1
Bowel Perforation	1	1
Urinary Incontinence	1	1
Liver Damage/Dysfunction	1	1
Unspecified Infection	1	1
Hypovolemic Shock	1	1
Abdominal Pain	1	1