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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	600	600
Material Fragmentation	531	533
Adverse Event Without Identified Device or Use Problem	286	286
Calcified	261	261
Difficult to Advance	174	174
Material Split, Cut or Torn	166	166
Migration	137	137
Detachment of Device or Device Component	132	132
Deformation Due to Compressive Stress	132	132
Material Deformation	130	130
Difficult to Remove	112	112
Patient Device Interaction Problem	108	108
Biocompatibility	89	89
Material Separation	78	78
Wrong Label	54	54
Material Twisted/Bent	43	43
Fracture	39	39
Material Too Rigid or Stiff	36	36
Unsealed Device Packaging	31	31
Device Dislodged or Dislocated	30	30
Difficult to Insert	29	29
Partial Blockage	27	27
Component Missing	27	27
Use of Device Problem	27	27
Premature Separation	26	26
Material Integrity Problem	25	25
Accessory Incompatible	25	26
Complete Blockage	21	21
Tear, Rip or Hole in Device Packaging	21	21
Component Misassembled	21	21
Device Contaminated During Manufacture or Shipping	20	20
Nonstandard Device	20	20
Device-Device Incompatibility	19	19
Device Contamination with Chemical or Other Material	19	19
Improper or Incorrect Procedure or Method	19	20
Defective Device	17	17
Inadequate Instructions for Healthcare Professional	17	17
Entrapment of Device	16	16
Off-Label Use	16	16
Obstruction of Flow	15	15
Packaging Problem	14	14
Flaked	12	13
Incorrect Measurement	11	11
Device Handling Problem	11	11
Device Markings/Labelling Problem	11	11
Inaccurate Flow Rate	10	10
Positioning Problem	10	10
Migration or Expulsion of Device	9	9
Peeled/Delaminated	8	8
Fluid/Blood Leak	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2321	2326
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	208	208
Pain	133	133
Insufficient Information	93	93
Foreign Body In Patient	93	94
Urinary Tract Infection	61	61
Discomfort	58	58
Hematuria	56	56
Unspecified Infection	50	50
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	19	19
Swelling/ Edema	19	19
Exposure to Body Fluids	14	14
Fever	14	14
Abdominal Pain	12	12
Urinary Frequency	11	11
Urinary Incontinence	11	11
Post Operative Wound Infection	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
Incontinence	4	4
Erosion	4	4
Urethral Stenosis/Stricture	3	3
Internal Organ Perforation	3	3
Irritability	3	3
Bacterial Infection	3	3
Tachycardia	3	3
Skin Discoloration	2	2
Kidney Infection	2	2
Device Embedded In Tissue or Plaque	2	2
Rash	2	2
Chills	2	2
Jaundice	2	2
Dyspnea	2	2
Fungal Infection	2	2
Unspecified Tissue Injury	2	2