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	671	671
Material Fragmentation	541	543
Adverse Event Without Identified Device or Use Problem	291	291
Calcified	273	273
Difficult to Advance	191	191
Material Split, Cut or Torn	178	178
Detachment of Device or Device Component	147	147
Deformation Due to Compressive Stress	142	142
Material Deformation	138	138
Migration	138	138
Patient Device Interaction Problem	122	122
Difficult to Remove	113	113
Biocompatibility	89	89
Material Separation	80	80
Wrong Label	54	54
Material Twisted/Bent	50	50
Nonstandard Device	46	46
Fracture	41	41
Material Too Rigid or Stiff	36	36
Unsealed Device Packaging	35	35
Difficult to Insert	34	34
Accessory Incompatible	32	33
Device Dislodged or Dislocated	32	32
Material Integrity Problem	28	28
Premature Separation	28	28
Partial Blockage	27	27
Use of Device Problem	27	27
Component Missing	27	27
Complete Blockage	25	25
Tear, Rip or Hole in Device Packaging	22	22
Component Misassembled	22	22
Device Contamination with Chemical or Other Material	21	21
Device Contaminated During Manufacture or Shipping	20	20
Device-Device Incompatibility	19	19
Improper or Incorrect Procedure or Method	19	20
Obstruction of Flow	17	17
Defective Device	17	17
Inadequate Instructions for Healthcare Professional	17	17
Entrapment of Device	17	17
Off-Label Use	16	16
Flaked	15	16
Separation Failure	14	14
Packaging Problem	14	14
Device Handling Problem	12	12
Device Markings/Labelling Problem	11	11
Incorrect Measurement	11	11
Inaccurate Flow Rate	10	10
Positioning Problem	10	10
Migration or Expulsion of Device	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	2488	2493
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	224	224
Pain	138	138
Foreign Body In Patient	106	107
Insufficient Information	94	94
Urinary Tract Infection	61	61
Hematuria	61	61
Discomfort	60	60
Unspecified Infection	52	52
Obstruction/Occlusion	39	39
Unspecified Kidney or Urinary Problem	35	35
Calcium Deposits/Calcification	25	25
Micturition Urgency	22	22
Sepsis	21	21
Dysuria	21	21
No Consequences Or Impact To Patient	21	21
Hemorrhage/Bleeding	20	20
Swelling/ Edema	20	20
Fever	16	16
Exposure to Body Fluids	15	15
Abdominal Pain	12	12
Urinary Retention	11	11
Urinary Incontinence	11	11
Urinary Frequency	11	11
Post Operative Wound Infection	11	11
Vomiting	9	9
Laceration(s)	8	8
Perforation	8	8
No Code Available	8	8
Fistula	7	7
Inflammation	6	6
Skin Inflammation/ Irritation	6	6
Hypersensitivity/Allergic reaction	6	6
No Patient Involvement	6	6
Incontinence	4	4
Erosion	4	4
Bacterial Infection	3	3
Tachycardia	3	3
Urethral Stenosis/Stricture	3	3
Irritability	3	3
Internal Organ Perforation	3	3
Unspecified Tissue Injury	2	2
Renal Failure	2	2
Extravasation	2	2
Device Embedded In Tissue or Plaque	2	2
Kidney Infection	2	2
Dyspnea	2	2
Jaundice	2	2
Chills	2	2
Rash	2	2