TPLC - Total Product Life Cycle

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Device	catheter, retention type, balloon
Regulation Description	Urological catheter and accessories.
Product Code	EZL
Regulation Number	876.5130
Device Class	2

Premarket Reviews
Manufacturer	Decision
APOLLON CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT	1
FLUME CATHETER COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU PRIMECARE MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HR PHARMACEUTICALS, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K200556 AquaFlate Pre-Filled Sterile Water Syringe 10mL
INNOCARE UROLOGICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
PATHWAY, LLC
	SUBSTANTIALLY EQUIVALENT	1
POTRERO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
SENTINEL MEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SILQ TECHNOLOGIES CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SILQ TECHNOLOGIES, CORP.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
THE FLUME CATHETER COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	569	569
Material Puncture/Hole	469	469
Fluid/Blood Leak	391	391
Difficult to Remove	268	268
Material Rupture	265	265
Deflation Problem	246	246
Decrease in Pressure	237	237
Material Invagination	180	180
Material Split, Cut or Torn	174	174
Adverse Event Without Identified Device or Use Problem	122	122
Material Fragmentation	121	121
Break	119	119
Partial Blockage	119	119
Inflation Problem	106	106
Erratic or Intermittent Display	101	101
Leak/Splash	87	87
Failure to Deflate	83	83
Failure to Infuse	82	82
Component Missing	65	65
Inaccurate Flow Rate	65	65
Component Misassembled	57	57
Device Contamination with Chemical or Other Material	57	57
Unintended Deflation	54	54
Fracture	47	47
Patient Device Interaction Problem	42	42
Obstruction of Flow	40	40
Device Fell	39	39
Device Dislodged or Dislocated	36	36
Detachment of Device or Device Component	35	35
Device Slipped	35	35
Insufficient Information	33	33
Wrong Label	32	32
Device Contaminated During Manufacture or Shipping	32	32
Material Integrity Problem	31	31
Material Protrusion/Extrusion	28	28
Incorrect Measurement	28	28
Material Twisted/Bent	28	28
Deformation Due to Compressive Stress	27	27
Dent in Material	26	26
No Flow	26	26
Appropriate Term/Code Not Available	25	25
Material Deformation	25	25
Calcified	24	24
Difficult to Insert	24	24
Tear, Rip or Hole in Device Packaging	22	22
Physical Resistance/Sticking	22	22
Short Fill	22	22
Biocompatibility	22	22
Complete Blockage	20	20
Material Separation	16	16

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3064	3064
No Consequences Or Impact To Patient	480	480
No Known Impact Or Consequence To Patient	270	270
Insufficient Information	256	256
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	243	243
Pain	235	235
Urinary Tract Infection	128	128
Discomfort	97	97
Hematuria	70	70
Foreign Body In Patient	67	67
Urinary Retention	64	64
No Patient Involvement	49	49
Hemorrhage/Bleeding	45	45
Patient Problem/Medical Problem	28	28
Unspecified Infection	18	18
Skin Inflammation/ Irritation	16	16
Genital Bleeding	15	15
Sepsis	12	12
No Code Available	12	12
Blood Loss	9	9
No Information	9	9
Exposure to Body Fluids	8	8
Unspecified Tissue Injury	8	8
Device Embedded In Tissue or Plaque	7	7
Urinary Incontinence	6	6
Skin Tears	6	6
Perforation	6	6
Tissue Breakdown	6	6
Incontinence	6	6
Injury	6	6
Cramp(s) /Muscle Spasm(s)	5	5
Fistula	5	5
Fever	5	5
Burning Sensation	5	5
Pressure Sores	4	4
Inflammation	4	4
Cancer	4	4
Unspecified Kidney or Urinary Problem	4	4
Internal Organ Perforation	4	4
Death	4	4
Erosion	3	3
Ulcer	3	3
Swelling/ Edema	3	3
Necrosis	3	3
Dizziness	3	3
Dysuria	3	3
Anxiety	3	3
Abrasion	3	3
Anemia	3	3
Local Reaction	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard Inc	II	Sep-23-2021
2	Cardinal Health 200, LLC	I	Feb-16-2024
3	Coloplast Manufacturing US, LLC	II	Jan-10-2025
4	Degania Medical Devices Pvt. Ltd.	II	Apr-23-2020
5	Degania Silicone, Ltd.	II	Jan-13-2020
6	Medline Industries Inc	II	May-18-2020
7	Nurse Assist, LLC	I	Dec-20-2023