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
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	572	572
Material Puncture/Hole	491	491
Fluid/Blood Leak	399	399
Difficult to Remove	273	273
Material Rupture	271	271
Deflation Problem	250	250
Decrease in Pressure	237	237
Material Invagination	183	183
Material Split, Cut or Torn	179	179
Material Fragmentation	124	124
Adverse Event Without Identified Device or Use Problem	122	122
Break	119	119
Partial Blockage	119	119
Inflation Problem	109	109
Erratic or Intermittent Display	101	101
Leak/Splash	87	87
Failure to Deflate	84	84
Failure to Infuse	82	82
Inaccurate Flow Rate	66	66
Component Missing	65	65
Device Contamination with Chemical or Other Material	58	58
Component Misassembled	57	57
Unintended Deflation	54	54
Fracture	47	47
Patient Device Interaction Problem	43	43
Obstruction of Flow	40	40
Device Fell	39	39
Device Dislodged or Dislocated	37	37
Device Slipped	35	35
Detachment of Device or Device Component	35	35
Wrong Label	34	34
Insufficient Information	33	33
Device Contaminated During Manufacture or Shipping	32	32
Material Integrity Problem	31	31
Appropriate Term/Code Not Available	29	29
Deformation Due to Compressive Stress	29	29
Incorrect Measurement	29	29
Material Twisted/Bent	28	28
Material Protrusion/Extrusion	28	28
No Flow	27	27
Dent in Material	26	26
Difficult to Insert	25	25
Material Deformation	25	25
Calcified	24	24
Biocompatibility	22	22
Physical Resistance/Sticking	22	22
Tear, Rip or Hole in Device Packaging	22	22
Short Fill	22	22
Complete Blockage	20	20
Material Separation	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3123	3123
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	251	251
Pain	243	243
Urinary Tract Infection	128	128
Discomfort	99	99
Hematuria	72	72
Foreign Body In Patient	67	67
Urinary Retention	64	64
No Patient Involvement	49	49
Hemorrhage/Bleeding	48	48
Patient Problem/Medical Problem	28	28
Unspecified Infection	18	18
Skin Inflammation/ Irritation	17	17
Genital Bleeding	16	16
No Code Available	12	12
Sepsis	12	12
Exposure to Body Fluids	11	11
Blood Loss	9	9
No Information	9	9
Unspecified Tissue Injury	8	8
Device Embedded In Tissue or Plaque	7	7
Tissue Breakdown	6	6
Urinary Incontinence	6	6
Incontinence	6	6
Perforation	6	6
Injury	6	6
Skin Tears	6	6
Cramp(s) /Muscle Spasm(s)	5	5
Fistula	5	5
Fever	5	5
Burning Sensation	5	5
Unspecified Kidney or Urinary Problem	4	4
Death	4	4
Pressure Sores	4	4
Inflammation	4	4
Cancer	4	4
Internal Organ Perforation	4	4
Distress	4	4
Micturition Urgency	3	3
Kidney Infection	3	3
Cellulitis	3	3
Erosion	3	3
Anemia	3	3
Abrasion	3	3
Dizziness	3	3
Ulcer	3	3
Skin Discoloration	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