TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, suprapubic (and accessories)
Product Code	KOB
Regulation Number	876.5090
Device Class	2

Premarket Reviews
Manufacturer	Decision
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	2
MEDIPLUS LTD.
	SUBSTANTIALLY EQUIVALENT	1
SWAN VALLEY MEDICAL, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	9	9
Deflation Problem	6	6
Leak/Splash	5	5
Device Dislodged or Dislocated	5	5
Material Separation	3	3
Device Operates Differently Than Expected	3	3
Detachment Of Device Component	3	3
Fluid/Blood Leak	2	2
Unraveled Material	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Detachment of Device or Device Component	2	2
Torn Material	1	1
Unintended Movement	1	1
Insufficient Information	1	1
Physical Resistance/Sticking	1	1
Difficult to Advance	1	1
Device Slipped	1	1
Device Contamination with Chemical or Other Material	1	1
Material Twisted/Bent	1	1
No Flow	1	1
Material Perforation	1	1
Component Missing	1	1
Contamination /Decontamination Problem	1	1
Migration or Expulsion of Device	1	1
Occlusion Within Device	1	1
No Device Output	1	1
Unsealed Device Packaging	1	1
Difficult To Position	1	1
Material Fragmentation	1	1
Inflation Problem	1	1
Component Falling	1	1
Burst Container or Vessel	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	15	15
No Consequences Or Impact To Patient	10	10
No Known Impact Or Consequence To Patient	8	8
No Clinical Signs, Symptoms or Conditions	4	4
Foreign Body In Patient	2	2
Device Embedded In Tissue or Plaque	2	2
No Information	2	2
Bacterial Infection	1	1
Peritonitis	1	1
Pain	1	1
Foreign body, removal of	1	1
Fever	1	1
Hematuria	1	1
Internal Organ Perforation	1	1
Other (for use when an appropriate patient code cannot be identified)	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Failure of Implant	1	1