TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	2
CATHEGENIX (XIAMEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT - KIT	1
COLOPLAST CORP.
	SUBSTANTIALLY EQUIVALENT - KIT	2
	SUBSTANTIALLY EQUIVALENT	1
ROCAMED SAM
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN TRIOUS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
URETERAL STENT COMPANY
	SUBSTANTIALLY EQUIVALENT	2
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	713	713
Material Fragmentation	543	544
Adverse Event Without Identified Device or Use Problem	299	299
Calcified	285	285
Difficult to Advance	206	206
Material Split, Cut or Torn	180	180
Detachment of Device or Device Component	158	158
Deformation Due to Compressive Stress	156	156
Material Deformation	146	146
Migration	141	141
Patient Device Interaction Problem	127	127
Difficult to Remove	115	115
Biocompatibility	91	91
Material Separation	80	80
Nonstandard Device	69	69
Wrong Label	54	54
Material Twisted/Bent	51	51
Fracture	44	44
Unsealed Device Packaging	41	41
Device Dislodged or Dislocated	38	38
Accessory Incompatible	37	38
Difficult to Insert	35	35
Material Too Rigid or Stiff	34	34
Material Integrity Problem	29	29
Complete Blockage	28	28
Premature Separation	28	28
Partial Blockage	27	27
Component Missing	27	27
Use of Device Problem	27	27
Device Stenosis	26	26
Device Contamination with Chemical or Other Material	24	24
Component Misassembled	22	22
Tear, Rip or Hole in Device Packaging	22	22
Device Contaminated During Manufacture or Shipping	20	20
Improper or Incorrect Procedure or Method	20	21
Device-Device Incompatibility	19	19
Separation Failure	17	17
Obstruction of Flow	17	17
Inadequate Instructions for Healthcare Professional	17	17
Off-Label Use	16	16
Flaked	16	17
Packaging Problem	14	14
Defective Device	14	14
Entrapment of Device	14	14
Device Handling Problem	13	13
Incorrect Measurement	11	11
Inaccurate Flow Rate	10	10
Migration or Expulsion of Device	10	10
Device Markings/Labelling Problem	9	9
Delivered as Unsterile Product	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2628	2633
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	227	227
Pain	146	146
Foreign Body In Patient	114	115
Insufficient Information	98	98
Hematuria	64	64
Urinary Tract Infection	63	63
Discomfort	63	63
Unspecified Infection	56	56
Obstruction/Occlusion	42	42
Unspecified Kidney or Urinary Problem	39	39
Calcium Deposits/Calcification	27	27
Micturition Urgency	24	24
Renal Failure	23	23
Dysuria	23	23
Sepsis	22	22
Hemorrhage/Blood Loss/Bleeding	21	21
Swelling/ Edema	21	21
No Consequences Or Impact To Patient	21	21
Exposure to Body Fluids	18	18
Fever	17	17
Urinary Frequency / Polyuria	13	13
Abdominal Pain	12	12
Urinary Retention	12	12
Urinary Incontinence	11	11
Post Operative Wound Infection	11	11
Vomiting	9	9
No Code Available	8	8
Laceration(s)	8	8
Perforation	8	8
Fistula	7	7
No Patient Involvement	6	6
Inflammation	6	6
Skin Inflammation/ Irritation	6	6
Hypersensitivity/Allergic reaction	6	6
Incontinence	4	4
Erosion	4	4
Tachycardia	4	4
Hydronephrosis	3	3
Internal Organ Perforation	3	3
Irritability	3	3
Cramp(s) /Muscle Spasm(s)	3	3
Urethral Stenosis/Stricture	3	3
Abrasion	3	3
Bacterial Infection	3	3
Urolithiasis	3	3
Rash	2	2
Chills	2	2
Skin Discoloration	2	2
Jaundice	2	2