TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
RIGICON INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	352	352
Adverse Event Without Identified Device or Use Problem	229	229
Inadequacy of Device Shape and/or Size	76	76
Mechanical Problem	71	71
Defective Device	56	56
Migration	50	50
Fracture	29	29
Malposition of Device	26	26
Break	18	18
Material Puncture/Hole	13	13
Appropriate Term/Code Not Available	10	10
Use of Device Problem	9	9
Fluid/Blood Leak	6	6
Material Erosion	5	5
Device Appears to Trigger Rejection	5	5
Positioning Problem	5	5
Material Too Soft/Flexible	4	4
Material Protrusion/Extrusion	3	3
No Apparent Adverse Event	3	3
Noise, Audible	3	3
Difficult to Insert	3	3
Migration or Expulsion of Device	3	3
Inflation Problem	2	2
Material Deformation	2	2
Device Dislodged or Dislocated	2	2
Patient Device Interaction Problem	2	2
Material Twisted/Bent	2	2
Missing Information	1	1
Pumping Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Device Contamination with Chemical or Other Material	1	1
Patient-Device Incompatibility	1	1
Detachment of Device or Device Component	1	1
Device Markings/Labelling Problem	1	1
Crack	1	1
Deflation Problem	1	1
Degraded	1	1
Material Discolored	1	1
Peeled/Delaminated	1	1
Material Too Rigid or Stiff	1	1
Microbial Contamination of Device	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	243	243
No Known Impact Or Consequence To Patient	193	193
Unspecified Infection	125	125
Pain	99	99
Erosion	88	88
Perforation	55	55
Discomfort	38	38
Insufficient Information	33	33
No Information	32	32
No Consequences Or Impact To Patient	29	29
Bacterial Infection	19	19
Inflammation	10	10
Wound Dehiscence	10	10
Skin Erosion	9	9
Necrosis	8	8
Hematoma	7	7
Swelling/ Edema	7	7
Purulent Discharge	6	6
Unspecified Tissue Injury	5	5
Fluid Discharge	4	4
Complaint, Ill-Defined	4	4
Deformity/ Disfigurement	4	4
Scarring	4	4
Fistula	4	4
Failure of Implant	4	4
Tissue Damage	3	3
Irritation	3	3
Injury	3	3
Post Operative Wound Infection	3	3
No Patient Involvement	2	2
Depression	2	2
Numbness	2	2
Fungal Infection	2	2
Skin Inflammation/ Irritation	2	2
Sexual Dysfunction	2	2
Hemorrhage/Bleeding	2	2
Hypersensitivity/Allergic reaction	2	2
Fever	2	2
Edema	2	2
Abscess	2	2
Urinary Retention	2	2
Urinary Tract Infection	2	2
Burning Sensation	2	2
Swelling	1	1
Ulcer	1	1
Urinary Frequency	1	1
Pocket Erosion	1	1
Rash	1	1
Scar Tissue	1	1
Bruise/Contusion	1	1
Emotional Changes	1	1
Ecchymosis	1	1
Myocardial Infarction	1	1
Localized Skin Lesion	1	1
Obstruction/Occlusion	1	1
Sensitivity of Teeth	1	1
Sweating	1	1
Impaired Healing	1	1
Fibrosis	1	1
No Code Available	1	1
Urethral Stenosis/Stricture	1	1
Unspecified Kidney or Urinary Problem	1	1
Dyspareunia	1	1