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	323	323
Difficult to Remove	48	48
Adverse Event Without Identified Device or Use Problem	47	47
Biocompatibility	43	43
Physical Resistance/Sticking	28	28
Patient Device Interaction Problem	15	15
Loss of or Failure to Bond	12	12
Inadequacy of Device Shape and/or Size	10	10
Material Deformation	8	8
Patient-Device Incompatibility	7	7
Missing Information	7	7
Inadequate Instructions for Healthcare Professional	7	7
Component Missing	6	6
Product Quality Problem	5	5
Device Handling Problem	5	5
Inaccurate Flow Rate	5	6
Therapeutic or Diagnostic Output Failure	5	5
Fluid/Blood Leak	4	4
Inadequate or Insufficient Training	4	4
Material Twisted/Bent	4	4
Use of Device Problem	4	4
Expiration Date Error	4	4
Leak/Splash	4	4
Material Too Rigid or Stiff	3	3
Material Integrity Problem	3	3
Defective Device	3	3
Sharp Edges	3	3
Component Misassembled	3	3
Illegible Information	3	3
Backflow	2	2
Obstruction of Flow	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Defective Component	2	2
Labelling, Instructions for Use or Training Problem	2	2
Detachment of Device or Device Component	2	2
Device Markings/Labelling Problem	2	2
Restricted Flow rate	2	2
Deformation Due to Compressive Stress	2	3
Positioning Failure	1	1
Improper Flow or Infusion	1	1
Decrease in Pressure	1	1
Structural Problem	1	1
Partial Blockage	1	1
Wrong Label	1	1
Insufficient Information	1	1
Device Contamination with Chemical or Other Material	1	1
No Apparent Adverse Event	1	1
Unintended Movement	1	1
Appropriate Term/Code Not Available	1	1
Material Too Soft/Flexible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	183	185
No Consequences Or Impact To Patient	114	114
Urinary Tract Infection	60	60
No Known Impact Or Consequence To Patient	52	52
Pain	50	50
Skin Inflammation/ Irritation	48	48
Skin Tears	36	36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	30	30
Unspecified Infection	19	19
Tissue Breakdown	14	14
Pressure Sores	13	13
Patient Problem/Medical Problem	11	11
Irritation	9	9
Discomfort	8	8
No Code Available	8	8
Skin Discoloration	6	6
Abrasion	5	5
Rash	5	5
Hemorrhage/Bleeding	5	5
Injury	4	4
Skin Irritation	4	4
Swelling/ Edema	3	3
Hypersensitivity/Allergic reaction	3	3
Blood Loss	2	2
No Information	2	2
Hematuria	2	2
Insufficient Information	2	2
Fungal Infection	2	2
Bacterial Infection	2	2
Adhesion(s)	1	1
Local Reaction	1	1
Blister	1	1
Localized Skin Lesion	1	1
Fever	1	1
Erythema	1	1
Swelling	1	1
Necrosis	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Reaction	1	1
Contact Dermatitis	1	1
Tissue Damage	1	1
Complaint, Ill-Defined	1	1
Irritability	1	1
Bruise/Contusion	1	1
Skin Infection	1	1