TPLC - Total Product Life Cycle

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Device	catheter, straight
Regulation Description	Urological catheter and accessories.
Product Code	EZD
Regulation Number	876.5130
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIG BLUE BIOTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
BONREE MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHENGDU DAXAN INNOVATIVE MEDICAL TECH. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
COLOPLAST
	SUBSTANTIALLY EQUIVALENT	6
COLOPLAST CORP.
	SUBSTANTIALLY EQUIVALENT	5
CONVATEC
	SUBSTANTIALLY EQUIVALENT	2
CONVATEC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CONVATEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU JIMUSHI MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOLLISTER INCORPORATED
	SUBSTANTIALLY EQUIVALENT	5
HR HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	1
JAMJOOM FULLCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WELLSPECT AB
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	601	602
Defective Device	555	555
Improper Chemical Reaction	391	391
Sharp Edges	239	239
Difficult to Remove	161	162
Biocompatibility	151	151
Product Quality Problem	138	138
Difficult to Insert	129	129
Component Misassembled	123	123
Incorrect Measurement	112	112
Material Twisted/Bent	79	79
Material Fragmentation	57	57
Tear, Rip or Hole in Device Packaging	56	56
Unsealed Device Packaging	48	48
Delivered as Unsterile Product	45	45
Difficult to Open or Close	41	41
Inaccurate Flow Rate	41	41
Device Handling Problem	40	41
Component Missing	40	40
Contamination /Decontamination Problem	34	34
Patient-Device Incompatibility	33	33
Inadequacy of Device Shape and/or Size	33	33
Insufficient Information	31	31
Patient Device Interaction Problem	31	31
Nonstandard Device	29	29
Material Integrity Problem	27	27
Material Protrusion/Extrusion	24	24
Break	23	23
Manufacturing, Packaging or Shipping Problem	22	22
Fluid/Blood Leak	15	15
Device Damaged Prior to Use	13	13
Therapeutic or Diagnostic Output Failure	13	13
Defective Component	12	12
Use of Device Problem	12	12
Misassembled	11	11
Material Too Soft/Flexible	10	10
Material Deformation	9	9
Short Fill	9	9
Material Too Rigid or Stiff	9	9
Difficult to Open or Remove Packaging Material	8	8
Scratched Material	8	8
Device Misassembled During Manufacturing /Shipping	8	8
Material Split, Cut or Torn	7	7
No Flow	7	7
Incomplete or Missing Packaging	7	7
Material Disintegration	7	7
Off-Label Use	6	6
Partial Blockage	6	6
Structural Problem	6	6
Leak/Splash	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1542	1544
Urinary Tract Infection	736	738
No Consequences Or Impact To Patient	282	282
Pain	209	209
No Known Impact Or Consequence To Patient	184	184
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	152	152
Hemorrhage/Bleeding	124	124
Discomfort	83	83
Unspecified Infection	63	63
Patient Problem/Medical Problem	42	42
No Patient Involvement	36	36
Sepsis	29	29
Abrasion	27	27
No Code Available	21	21
Unspecified Tissue Injury	19	19
Hematuria	14	14
Tissue Breakdown	12	12
Burning Sensation	12	12
Blood Loss	10	10
Skin Tears	9	9
Foreign Body In Patient	9	9
Irritation	9	9
Genital Bleeding	9	9
Skin Inflammation/ Irritation	8	8
Insufficient Information	8	16
Rash	8	8
Laceration(s)	7	7
Irritability	7	7
Fever	7	7
Injury	6	6
Hypersensitivity/Allergic reaction	6	6
Bacterial Infection	5	5
Nausea	3	3
Skin Irritation	3	3
Fungal Infection	3	3
Headache	3	3
Thrombus	3	3
Local Reaction	3	3
Bruise/Contusion	3	4
Cancer	2	2
Dysuria	2	2
Chills	2	2
Anemia	2	2
Erythema	2	2
Swelling	2	2
Urinary Retention	2	2
Vomiting	2	2
Abdominal Cramps	2	2
Inflammation	2	2
Swelling/ Edema	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard Inc	II	Jun-08-2023
2	Wellspect HealthCare (Division of DENTSPLY IH AB)	II	Jul-17-2020