TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	60	60
Burst Container or Vessel	59	59
Fracture	19	19
Break	17	17
Fluid/Blood Leak	14	14
Material Deformation	14	14
Material Rupture	14	14
Material Separation	12	12
Material Split, Cut or Torn	11	11
Inflation Problem	10	10
Physical Resistance/Sticking	9	9
Device Contamination with Chemical or Other Material	9	9
Detachment of Device or Device Component	8	8
Nonstandard Device	7	7
Difficult to Advance	7	7
Material Fragmentation	7	7
Material Puncture/Hole	6	6
Difficult to Remove	5	5
Device Contaminated During Manufacture or Shipping	4	4
Defective Device	4	4
Material Integrity Problem	4	4
Material Twisted/Bent	4	4
Appropriate Term/Code Not Available	3	3
Mechanical Jam	2	2
Deformation Due to Compressive Stress	2	2
Tear, Rip or Hole in Device Packaging	2	2
Product Quality Problem	2	2
Device Handling Problem	2	2
Use of Device Problem	2	2
Positioning Failure	2	2
Difficult to Insert	2	2
Unsealed Device Packaging	2	2
Separation Failure	2	2
Complete Blockage	2	2
Peeled/Delaminated	2	2
Crack	2	2
Difficult to Open or Remove Packaging Material	2	2
Leak/Splash	2	2
Unraveled Material	1	1
Component Missing	1	1
Obstruction of Flow	1	1
Gas/Air Leak	1	1
Inadequate Instructions for Healthcare Professional	1	1
Decrease in Pressure	1	1
Deflation Problem	1	1
Contamination	1	1
Therapeutic or Diagnostic Output Failure	1	1
Solder Joint Fracture	1	1
Device Fell	1	1
Failure to Capture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	187	187
No Consequences Or Impact To Patient	32	32
No Known Impact Or Consequence To Patient	22	22
Hemorrhage/Bleeding	15	15
Insufficient Information	14	14
Sepsis	13	13
Obstruction/Occlusion	11	11
Renal Failure	7	7
Urinary Tract Infection	6	6
Foreign Body In Patient	6	6
No Code Available	5	5
Hematuria	5	5
Septic Shock	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Perforation	4	4
Pain	4	4
Unspecified Kidney or Urinary Problem	4	4
Pseudoaneurysm	3	3
Respiratory Failure	2	2
Pneumothorax	2	2
Failure of Implant	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
No Patient Involvement	1	1
Urinary Retention	1	1
Transient Ischemic Attack	1	1
Deposits	1	1
Cellulitis	1	1
Cardiac Arrest	1	1
Purulent Discharge	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