TPLC - Total Product Life Cycle

show TPLC since

Device	device, cystometric, hydraulic
Product Code	FEN
Regulation Number	876.1620
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	9	9
Deflation Problem	9	9
No Flow	9	9
Calibration Problem	5	5
Material Protrusion/Extrusion	4	4
Defective Component	4	4
Device Operates Differently Than Expected	4	4
Infusion or Flow Problem	3	3
Obstruction of Flow	3	3
Partial Blockage	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Blocked Connection	3	3
Output Problem	3	3
Crack	2	2
Break	2	2
No Device Output	2	2
Disconnection	2	2
Inflation Problem	2	2
Device Operational Issue	1	1
Gas/Air Leak	1	1
Display Difficult to Read	1	1
Device Dislodged or Dislocated	1	1
Loss of or Failure to Bond	1	1
Difficult to Open or Close	1	1
Deformation Due to Compressive Stress	1	1
Device Displays Incorrect Message	1	1
Connection Problem	1	1
High Readings	1	1
Device Difficult to Program or Calibrate	1	1
Increase in Pressure	1	1
Scratched Material	1	1
Defective Device	1	1
Torn Material	1	1
Device Slipped	1	1
Fluid/Blood Leak	1	1
Detachment of Device or Device Component	1	1
Display or Visual Feedback Problem	1	1
Device Or Device Fragments Location Unknown	1	1
Reset Problem	1	1
Sticking	1	1
Hole In Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	39	39
No Clinical Signs, Symptoms or Conditions	10	10
Urinary Retention	9	9
No Information	4	4
Pain	2	2
Insufficient Information	2	2
Hemorrhage/Bleeding	2	2
High Blood Pressure/ Hypertension	1	1
Vessel Or Plaque, Device Embedded In	1	1
Abrasion	1	1
Death	1	1
No Consequences Or Impact To Patient	1	1
Obstruction/Occlusion	1	1
Foreign Body In Patient	1	1
Tissue Damage	1	1
No Code Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ConvaTec, Inc	II	Aug-10-2018
2	LABORIE MEDICAL TECHNOLOGIES, CORP	II	Jul-25-2019