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	636	636
Material Fragmentation	534	536
Adverse Event Without Identified Device or Use Problem	287	287
Calcified	267	267
Difficult to Advance	180	180
Material Split, Cut or Torn	173	173
Detachment of Device or Device Component	139	139
Migration	138	138
Deformation Due to Compressive Stress	136	136
Material Deformation	133	133
Difficult to Remove	113	113
Patient Device Interaction Problem	109	109
Biocompatibility	89	89
Material Separation	80	80
Wrong Label	54	54
Material Twisted/Bent	46	46
Fracture	40	40
Material Too Rigid or Stiff	36	36
Unsealed Device Packaging	35	35
Difficult to Insert	30	30
Device Dislodged or Dislocated	30	30
Nonstandard Device	28	28
Accessory Incompatible	28	29
Partial Blockage	27	27
Component Missing	27	27
Use of Device Problem	27	27
Material Integrity Problem	27	27
Premature Separation	27	27
Tear, Rip or Hole in Device Packaging	22	22
Complete Blockage	21	21
Component Misassembled	21	21
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
Defective Device	17	17
Entrapment of Device	17	17
Inadequate Instructions for Healthcare Professional	17	17
Off-Label Use	16	16
Obstruction of Flow	15	15
Packaging Problem	14	14
Device Handling Problem	12	12
Flaked	12	13
Device Markings/Labelling Problem	11	11
Incorrect Measurement	11	11
Inaccurate Flow Rate	10	10
Positioning Problem	10	10
Separation Failure	9	9
Migration or Expulsion of Device	9	9
Fluid/Blood Leak	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2397	2402
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	215	215
Pain	133	133
Foreign Body In Patient	97	98
Insufficient Information	94	94
Urinary Tract Infection	61	61
Discomfort	58	58
Hematuria	56	56
Unspecified Infection	51	51
Obstruction/Occlusion	39	39
Unspecified Kidney or Urinary Problem	33	33
Calcium Deposits/Calcification	24	24
Micturition Urgency	22	22
No Consequences Or Impact To Patient	21	21
Sepsis	21	21
Dysuria	21	21
Hemorrhage/Bleeding	20	20
Swelling/ Edema	19	19
Fever	16	16
Exposure to Body Fluids	14	14
Abdominal Pain	12	12
Post Operative Wound Infection	11	11
Urinary Frequency	11	11
Urinary Incontinence	11	11
Urinary Retention	10	10
Vomiting	9	9
Laceration(s)	8	8
No Code Available	8	8
Fistula	7	7
Perforation	6	6
Inflammation	6	6
No Patient Involvement	6	6
Skin Inflammation/ Irritation	5	5
Hypersensitivity/Allergic reaction	5	5
Erosion	4	4
Incontinence	4	4
Urethral Stenosis/Stricture	3	3
Internal Organ Perforation	3	3
Irritability	3	3
Bacterial Infection	3	3
Tachycardia	3	3
Kidney Infection	2	2
Device Embedded In Tissue or Plaque	2	2
Unspecified Tissue Injury	2	2
Renal Failure	2	2
Extravasation	2	2
Dyspnea	2	2
Jaundice	2	2
Fungal Infection	2	2
Rash	2	2