TPLC - Total Product Life Cycle

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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
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	614	614
Fluid/Blood Leak	483	483
Deflation Problem	415	415
Material Puncture/Hole	352	352
Difficult to Remove	294	294
Decrease in Pressure	237	237
Material Invagination	199	199
Material Rupture	195	195
Break	182	182
Material Split, Cut or Torn	160	160
Leak/Splash	128	128
Partial Blockage	121	121
Adverse Event Without Identified Device or Use Problem	112	112
Erratic or Intermittent Display	103	103
Inflation Problem	101	101
Material Fragmentation	95	95
Failure to Infuse	91	91
Device Fell	68	68
Component Missing	67	67
Inaccurate Flow Rate	65	65
Failure to Deflate	62	62
Device Dislodged or Dislocated	62	62
Device Contamination with Chemical or Other Material	50	50
Unintended Deflation	49	49
Obstruction of Flow	48	48
Detachment of Device or Device Component	46	46
Component Misassembled	46	46
Device Slipped	46	46
Material Deformation	42	42
Fracture	40	40
Patient Device Interaction Problem	39	39
Material Integrity Problem	38	38
No Flow	34	34
Physical Resistance/Sticking	32	32
Incorrect Measurement	30	30
Material Protrusion/Extrusion	29	29
Material Twisted/Bent	28	28
Deformation Due to Compressive Stress	26	26
Dent in Material	26	26
Difficult to Insert	25	25
Tear, Rip or Hole in Device Packaging	24	24
Short Fill	23	23
Patient-Device Incompatibility	23	23
Insufficient Information	23	23
Appropriate Term/Code Not Available	23	23
Biocompatibility	22	22
Complete Blockage	20	20
Calcified	20	20
Device Contaminated During Manufacture or Shipping	18	18
Wrong Label	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2428	2428
No Consequences Or Impact To Patient	898	898
No Known Impact Or Consequence To Patient	662	662
Pain	230	230
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	212	212
Insufficient Information	197	197
Urinary Tract Infection	112	112
No Patient Involvement	90	90
Discomfort	85	85
Foreign Body In Patient	62	62
Patient Problem/Medical Problem	60	60
Urinary Retention	60	60
Hematuria	55	55
Hemorrhage/Bleeding	53	53
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
Injury	7	7
Fever	7	7
Sepsis	7	7
Unspecified Tissue Injury	6	6
Skin Tears	6	6
Urinary Incontinence	6	6
Perforation	6	6
Tissue Breakdown	6	6
Inflammation	5	5
Incontinence	5	5
Exposure to Body Fluids	5	5
Burning Sensation	5	5
Local Reaction	4	4
Laceration(s)	4	4
Internal Organ Perforation	4	4
Death	4	4
Tissue Damage	3	3
Swelling/ Edema	3	3
Anxiety	3	3
Necrosis	3	3
Unspecified Kidney or Urinary Problem	3	3
Abrasion	3	3
Cancer	3	3
Fistula	3	3
Muscle Spasm(s)	3	3
Cellulitis	3	3
Skin Discoloration	3	3
Sweating	3	3
Rash	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