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	375	375
Adverse Event Without Identified Device or Use Problem	258	258
Inadequacy of Device Shape and/or Size	83	83
Mechanical Problem	75	75
Migration	59	59
Defective Device	58	58
Fracture	30	30
Malposition of Device	27	27
Break	19	19
Material Puncture/Hole	13	13
Appropriate Term/Code Not Available	10	10
Use of Device Problem	9	9
Fluid/Blood Leak	6	6
Device Appears to Trigger Rejection	5	5
Material Erosion	5	5
Positioning Problem	5	5
Material Too Soft/Flexible	4	4
Migration or Expulsion of Device	3	3
Noise, Audible	3	3
No Apparent Adverse Event	3	3
Difficult to Insert	3	3
Material Protrusion/Extrusion	3	3
Device Dislodged or Dislocated	2	2
Material Deformation	2	2
Inflation Problem	2	2
Material Twisted/Bent	2	2
Patient Device Interaction Problem	2	2
Component Missing	1	1
Material Too Rigid or Stiff	1	1
Material Discolored	1	1
Degraded	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1
Microbial Contamination of Device	1	1
Missing Information	1	1
Deflation Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Patient-Device Incompatibility	1	1
Pumping Problem	1	1
Device Markings/Labelling Problem	1	1
Peeled/Delaminated	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	280	280
No Known Impact Or Consequence To Patient	193	193
Unspecified Infection	138	138
Pain	110	110
Erosion	101	101
Perforation	58	58
Discomfort	42	42
Insufficient Information	36	36
No Information	32	32
No Consequences Or Impact To Patient	29	29
Bacterial Infection	19	19
Purulent Discharge	11	11
Wound Dehiscence	10	10
Necrosis	10	10
Inflammation	10	10
Failure of Implant	9	9
Swelling/ Edema	9	9
Skin Erosion	9	9
Hematoma	7	7
Unspecified Tissue Injury	6	6
Deformity/ Disfigurement	5	5
Fistula	4	4
Complaint, Ill-Defined	4	4
Scarring	4	4
Fluid Discharge	4	4
Tissue Damage	3	3
Injury	3	3
Irritation	3	3
Post Operative Wound Infection	3	3
Fever	2	2
Burning Sensation	2	2
Erythema	2	2
Urinary Retention	2	2
Depression	2	2
Numbness	2	2
No Patient Involvement	2	2
Unspecified Kidney or Urinary Problem	2	2
Abscess	2	2
Edema	2	2
Skin Inflammation/ Irritation	2	2
Fungal Infection	2	2
Hemorrhage/Bleeding	2	2
Hypersensitivity/Allergic reaction	2	2
Sexual Dysfunction	2	2
Urinary Tract Infection	2	2
Cellulitis	1	1
Cardiac Arrest	1	1
Rash	1	1
Localized Skin Lesion	1	1
Swelling	1	1