TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, retention type, balloon
Product Code	EZL
Regulation Number	876.5130
Device Class	2

Premarket Reviews
Manufacturer	Decision
APOLLON CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOSENSORS INTERNATIONAL PTE 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
INNOCARE UROLOGICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
PATHWAY, LLC
	SUBSTANTIALLY EQUIVALENT	1
POTRERO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
SAFE MEDICAL DESIGN
	SUBSTANTIALLY EQUIVALENT	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
URETHROTECH
	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	636	636
Fluid/Blood Leak	492	492
Deflation Problem	423	423
Material Puncture/Hole	397	397
Difficult to Remove	314	314
Decrease in Pressure	237	237
Material Rupture	208	208
Material Invagination	207	207
Break	184	184
Material Split, Cut or Torn	167	167
Leak/Splash	129	129
Partial Blockage	121	121
Adverse Event Without Identified Device or Use Problem	115	115
Inflation Problem	112	112
Erratic or Intermittent Display	106	106
Material Fragmentation	103	103
Failure to Infuse	92	92
Component Missing	72	72
Failure to Deflate	68	68
Device Fell	68	68
Inaccurate Flow Rate	67	67
Device Dislodged or Dislocated	62	62
Device Contamination with Chemical or Other Material	55	55
Component Misassembled	52	52
Unintended Deflation	51	51
Obstruction of Flow	50	50
Detachment of Device or Device Component	46	46
Device Slipped	46	46
Fracture	45	45
Material Deformation	42	42
Patient Device Interaction Problem	40	40
Material Integrity Problem	38	38
No Flow	34	34
Material Protrusion/Extrusion	32	32
Physical Resistance/Sticking	32	32
Material Twisted/Bent	32	32
Incorrect Measurement	30	30
Difficult to Insert	27	27
Dent in Material	26	26
Tear, Rip or Hole in Device Packaging	25	25
Short Fill	25	25
Deformation Due to Compressive Stress	25	25
Patient-Device Incompatibility	23	23
Appropriate Term/Code Not Available	23	23
Insufficient Information	23	23
Device Contaminated During Manufacture or Shipping	23	23
Biocompatibility	22	22
Complete Blockage	21	21
Calcified	20	20
Device Damaged Prior to Use	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2607	2607
No Consequences Or Impact To Patient	898	898
No Known Impact Or Consequence To Patient	662	662
Pain	240	240
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	217	217
Insufficient Information	211	211
Urinary Tract Infection	116	116
Discomfort	97	97
No Patient Involvement	90	90
Urinary Retention	66	66
Foreign Body In Patient	63	63
Patient Problem/Medical Problem	60	60
Hematuria	58	58
Hemorrhage/Bleeding	56	56
No Information	52	52
Unspecified Infection	21	21
Blood Loss	17	17
No Code Available	16	16
Genital Bleeding	15	15
Skin Inflammation/ Irritation	13	13
Device Embedded In Tissue or Plaque	8	8
Sepsis	8	8
Fever	7	7
Injury	7	7
Unspecified Tissue Injury	7	7
Incontinence	6	6
Perforation	6	6
Skin Tears	6	6
Urinary Incontinence	6	6
Tissue Breakdown	6	6
Inflammation	5	5
Exposure to Body Fluids	5	5
Burning Sensation	5	5
Unspecified Kidney or Urinary Problem	4	4
Laceration(s)	4	4
Local Reaction	4	4
Internal Organ Perforation	4	4
Death	4	4
Anxiety	3	3
Necrosis	3	3
Swelling/ Edema	3	3
Tissue Damage	3	3
Abrasion	3	3
Cancer	3	3
Cramp(s) /Muscle Spasm(s)	3	3
Muscle Spasm(s)	3	3
Cellulitis	3	3
Sweating	3	3
Skin Discoloration	3	3
Fistula	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	Degania Medical Devices Pvt. Ltd.	II	Apr-23-2020
4	Degania Silicone, Ltd.	II	Jan-13-2020
5	Medline Industries Inc	II	May-18-2020
6	Nurse Assist, LLC	I	Dec-20-2023