TPLC - Total Product Life Cycle

show TPLC since

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
GUANGDONG ECAN MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
H R PHARMACEUTICALS, INC.
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU PRIMECARE MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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
TELEFLEXMEDICAL, 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
Material Puncture/Hole	655	676
Burst Container or Vessel	592	596
Fluid/Blood Leak	458	467
Material Rupture	398	404
Difficult to Remove	310	314
Deflation Problem	268	268
Decrease in Pressure	237	243
Material Split, Cut or Torn	207	209
Material Invagination	190	202
Inflation Problem	167	167
Material Fragmentation	150	152
Adverse Event Without Identified Device or Use Problem	139	140
Break	126	127
Partial Blockage	121	121
Erratic or Intermittent Display	106	106
Failure to Deflate	98	98
Inaccurate Flow Rate	92	95
Leak/Splash	91	92
Failure to Infuse	80	85
Device Contamination with Chemical or Other Material	76	78
Component Missing	75	75
Component Misassembled	65	66
Unintended Deflation	65	65
Device Dislodged or Dislocated	59	60
Fracture	52	52
Obstruction of Flow	48	54
Patient Device Interaction Problem	45	45
Device Contaminated During Manufacture or Shipping	40	40
Device Fell	39	39
Detachment of Device or Device Component	38	38
Device Slipped	38	39
Wrong Label	38	38
Insufficient Information	37	37
Material Integrity Problem	35	35
Material Protrusion/Extrusion	33	36
Material Twisted/Bent	32	35
Complete Blockage	31	31
Deformation Due to Compressive Stress	31	32
Tear, Rip or Hole in Device Packaging	31	31
Incorrect Measurement	30	32
Appropriate Term/Code Not Available	29	29
Difficult to Insert	29	29
No Flow	29	29
Dent in Material	28	30
Material Deformation	26	27
Disconnection	26	26
Defective Device	25	25
Calcified	24	24
Physical Resistance/Sticking	23	26
Material Separation	22	22

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3713	3771
No Consequences Or Impact To Patient	480	480
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	295	306
Insufficient Information	289	297
No Known Impact Or Consequence To Patient	271	272
Pain	268	280
Urinary Tract Infection	150	151
Discomfort	116	119
Hematuria	78	78
Foreign Body In Patient	77	77
Urinary Retention	66	66
Hemorrhage/Bleeding	50	56
No Patient Involvement	49	49
Patient Problem/Medical Problem	28	28
Skin Inflammation/ Irritation	21	22
Unspecified Infection	20	20
Genital Bleeding	16	16
Exposure to Body Fluids	15	15
Sepsis	12	12
No Code Available	12	12
No Information	9	9
Blood Loss	9	9
Unspecified Tissue Injury	8	8
Device Embedded In Tissue or Plaque	7	7
Cramp(s) /Muscle Spasm(s)	7	7
Urinary Incontinence	6	6
Tissue Breakdown	6	6
Perforation	6	6
Injury	6	6
Skin Tears	6	6
Incontinence	6	6
Distress	5	5
Burning Sensation	5	5
Fever	5	5
Pressure Sores	5	5
Rash	5	5
Fistula	5	5
Unspecified Kidney or Urinary Problem	4	4
Septic Shock	4	4
Internal Organ Perforation	4	4
Inflammation	4	4
Death	4	4
Cancer	4	4
Abrasion	4	5
Laceration(s)	3	3
Micturition Urgency	3	3
Anxiety	3	3
Swelling/ Edema	3	3
Cellulitis	3	3
Skin Discoloration	3	5

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard Inc	II	Aug-28-2025
2	C.R. Bard Inc	II	Sep-23-2021
3	Cardinal Health 200, LLC	I	Feb-16-2024
4	Coloplast Manufacturing US, LLC	II	Jan-10-2025
5	Degania Medical Devices Pvt. Ltd.	II	Apr-23-2020
6	Degania Silicone, Ltd.	II	Jan-13-2020
7	Medline Industries Inc	II	May-18-2020
8	Nurse Assist, LLC	I	Dec-20-2023