TPLC - Total Product Life Cycle

show TPLC since

Device	device, incontinence, urosheath type, non-sterile
Regulation Description	Urine collector and accessories.
Definition	Urine collector and accessories; see product code EXJ
Product Code	NNX
Regulation Number	876.5250
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Nonstandard Device	190	190
Adverse Event Without Identified Device or Use Problem	24	24
Biocompatibility	23	23
Difficult to Remove	15	15
Patient Device Interaction Problem	15	15
Loss of or Failure to Bond	9	9
Material Deformation	7	7
Inadequacy of Device Shape and/or Size	7	7
Inadequate Instructions for Healthcare Professional	5	5
Device Handling Problem	5	5
Missing Information	5	5
Physical Resistance/Sticking	4	4
Expiration Date Error	4	4
Component Missing	4	4
Inaccurate Flow Rate	4	5
Inadequate or Insufficient Training	4	4
Fluid/Blood Leak	4	4
Material Twisted/Bent	3	3
Component Misassembled	3	3
Illegible Information	3	3
Deformation Due to Compressive Stress	2	3
Insufficient Information	1	1
Wrong Label	1	1
Positioning Failure	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Difficult to Open or Close	1	1
Improper Chemical Reaction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	168	170
Skin Inflammation/ Irritation	48	48
Urinary Tract Infection	41	41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	25	25
Pain	24	24
Skin Tears	19	19
Tissue Breakdown	13	13
Pressure Sores	11	11
Unspecified Infection	9	9
No Consequences Or Impact To Patient	9	9
Rash	5	5
Discomfort	5	5
Hypersensitivity/Allergic reaction	3	3
Abrasion	3	3
Skin Discoloration	3	3
Swelling/ Edema	3	3
Hemorrhage/Bleeding	3	3
No Code Available	2	2
Hematuria	2	2
Bacterial Infection	2	2
Skin Infection	1	1
Fungal Infection	1	1
Necrosis	1	1
Localized Skin Lesion	1	1
Blister	1	1
Local Reaction	1	1
Irritation	1	1
Injury	1	1
Fever	1	1
Contact Dermatitis	1	1
Irritability	1	1