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	564	564
Material Puncture/Hole	430	430
Fluid/Blood Leak	371	371
Difficult to Remove	264	264
Deflation Problem	242	242
Material Rupture	238	238
Decrease in Pressure	237	237
Material Invagination	179	179
Material Split, Cut or Torn	165	165
Adverse Event Without Identified Device or Use Problem	121	121
Break	119	119
Partial Blockage	118	118
Material Fragmentation	113	113
Erratic or Intermittent Display	101	101
Inflation Problem	91	91
Leak/Splash	84	84
Failure to Infuse	82	82
Failure to Deflate	81	81
Inaccurate Flow Rate	64	64
Component Missing	63	63
Device Contamination with Chemical or Other Material	56	56
Component Misassembled	54	54
Unintended Deflation	53	53
Fracture	46	46
Patient Device Interaction Problem	42	42
Obstruction of Flow	40	40
Device Fell	39	39
Device Slipped	34	34
Device Dislodged or Dislocated	33	33
Detachment of Device or Device Component	33	33
Device Contaminated During Manufacture or Shipping	32	32
Insufficient Information	31	31
Wrong Label	31	31
Material Integrity Problem	30	30
Incorrect Measurement	28	28
Material Twisted/Bent	28	28
Material Protrusion/Extrusion	27	27
Deformation Due to Compressive Stress	27	27
No Flow	26	26
Dent in Material	26	26
Material Deformation	25	25
Appropriate Term/Code Not Available	24	24
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
Gel Leak	16	16

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2940	2940
No Consequences Or Impact To Patient	480	480
No Known Impact Or Consequence To Patient	270	270
Insufficient Information	254	254
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	238	238
Pain	229	229
Urinary Tract Infection	127	127
Discomfort	96	96
Hematuria	66	66
Foreign Body In Patient	64	64
Urinary Retention	64	64
No Patient Involvement	49	49
Hemorrhage/Bleeding	44	44
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
Device Embedded In Tissue or Plaque	7	7
Unspecified Tissue Injury	7	7
Urinary Incontinence	6	6
Skin Tears	6	6
Injury	6	6
Perforation	6	6
Incontinence	6	6
Tissue Breakdown	6	6
Burning Sensation	5	5
Fever	5	5
Fistula	5	5
Cramp(s) /Muscle Spasm(s)	5	5
Pressure Sores	4	4
Cancer	4	4
Inflammation	4	4
Unspecified Kidney or Urinary Problem	4	4
Death	4	4
Internal Organ Perforation	4	4
Kidney Infection	3	3
Rash	3	3
Distress	3	3
Septic Shock	3	3
Skin Discoloration	3	3
Cellulitis	3	3
Sweating	3	3
Laceration(s)	3	3
Local Reaction	3	3
Anemia	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