TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
KINETIC INNOVATIVE SEATING SYSTEM LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	42	42
Appropriate Term/Code Not Available	10	10
Device Operates Differently Than Expected	9	9
Insufficient Information	8	8
Sticking	5	5
Product Quality Problem	4	4
Degraded	3	3
Fluid/Blood Leak	2	2
Detachment Of Device Component	2	2
Unstable	2	2
Bent	2	2
Crack	2	2
Detachment of Device or Device Component	2	2
Improper or Incorrect Procedure or Method	2	2
Material Integrity Problem	2	2
Adverse Event Without Identified Device or Use Problem	1	1
Positioning Problem	1	1
Torn Material	1	1
Misassembly by Users	1	1
Component Missing	1	1
Solder Joint Fracture	1	1
Failure to Advance	1	1
Material Deformation	1	1
Use of Device Problem	1	1
Material Rupture	1	1
Shipping Damage or Problem	1	1
Device Slipped	1	1
Component Falling	1	1
Collapse	1	1
Difficult to Fold, Unfold or Collapse	1	1
Gel Leak	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	35	35
No Consequences Or Impact To Patient	25	25
Pressure Sores	17	17
No Information	10	10
Fall	6	6
Injury	4	4
Ulcer	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Concussion	1	1
Insufficient Information	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Bruise/Contusion	1	1