TPLC - Total Product Life Cycle

show TPLC since

Device	collector, urine, powered, non indwelling catheter
Regulation Description	Urine collector and accessories.
Definition	For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair.
Product Code	NZU
Regulation Number	876.5250
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Decrease in Suction	1374	1378
Adverse Event Without Identified Device or Use Problem	741	741
Biocompatibility	453	454
Patient Device Interaction Problem	227	227
Increase in Suction	161	161
Device Handling Problem	119	119
Fluid/Blood Leak	113	113
Inadequate or Insufficient Training	112	112
Illegible Information	74	74
Overheating of Device	67	67
Suction Failure	45	45
Malposition of Device	43	43
Use of Device Problem	40	40
Positioning Failure	33	33
Missing Information	30	30
Component Missing	26	26
Nonstandard Device	22	22
Failure to Power Up	19	19
Patient-Device Incompatibility	13	13
Sharp Edges	12	12
Component Misassembled	11	11
Device Dislodged or Dislocated	10	10
Product Quality Problem	10	10
Misassembly by Users	10	10
Insufficient Device Problem Information	10	10
Disconnection	9	9
Loss of or Failure to Bond	5	5
No Apparent Adverse Event	5	5
Intermittent Loss of Power	5	5
Fracture	4	4
Inadequacy of Device Shape and/or Size	4	4
Difficult to Remove	4	4
Incorrect Measurement	4	4
Device Emits Odor	3	3
Material Too Soft/Flexible	3	3
Restricted Flow rate	3	3
Material Fragmentation	3	3
Physical Resistance/Sticking	2	2
Leak/Splash	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Failure to Pump	2	2
Material Separation	2	2
Inadequate Instructions for Healthcare Professional	2	2
Incomplete or Missing Packaging	2	2
Expiration Date Error	2	2
Defective Device	2	2
Material Invagination	1	2
Collapse	1	1
Misassembled	1	1
Pressure Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1669	1673
Urinary Tract Infection	1158	1160
Unspecified Infection	243	243
Skin Inflammation/ Irritation	191	191
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	122	123
Rash	110	110
Pressure Sore/Ulcer	86	86
Pain	84	85
Fungal Infection	82	83
Discomfort	53	53
Burning Sensation	44	44
Hypersensitivity/Allergic reaction	42	42
Tissue Breakdown	38	38
Bacterial Infection	34	34
Sepsis	31	31
Skin Discoloration	30	30
Blister	28	28
Itching Sensation	27	27
Skin Tears	26	26
Abrasion	21	21
Local Reaction	19	19
No Consequences Or Impact To Patient	18	18
Swelling/ Edema	18	18
Bruise/Contusion	18	18
Erythema	15	15
Irritation	14	14
No Code Available	11	11
Hematuria	10	10
No Known Impact Or Consequence To Patient	10	10
Unspecified Tissue Injury	10	10
Hemorrhage/Blood Loss/Bleeding	8	8
Kidney Infection	8	8
Insufficient Information	7	7
Patient Problem/Medical Problem	6	6
Fecal Incontinence	5	5
Skin Irritation	5	5
Urinary Incontinence	5	5
Abscess	5	5
Ulcer	5	5
Localized Skin Lesion	5	6
Incontinence	4	4
Electric Shock	3	3
Cyst(s)	3	3
Laceration(s)	3	3
Irritability	3	3
Reaction	3	3
Exposure to Body Fluids	3	3
Injury	2	2
Burn(s)	2	2
Renal Failure	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Sage Products Inc	II	Nov-21-2023