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	355	355
Adverse Event Without Identified Device or Use Problem	242	242
Inadequacy of Device Shape and/or Size	79	79
Mechanical Problem	73	73
Defective Device	58	58
Migration	54	54
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	252	252
No Known Impact Or Consequence To Patient	193	193
Unspecified Infection	130	130
Pain	104	104
Erosion	94	94
Perforation	57	57
Discomfort	40	40
Insufficient Information	34	34
No Information	32	32
No Consequences Or Impact To Patient	29	29
Bacterial Infection	19	19
Inflammation	10	10
Wound Dehiscence	10	10
Necrosis	10	10
Skin Erosion	9	9
Failure of Implant	8	8
Purulent Discharge	8	8
Hematoma	7	7
Swelling/ Edema	7	7
Unspecified Tissue Injury	6	6
Fluid Discharge	4	4
Complaint, Ill-Defined	4	4
Deformity/ Disfigurement	4	4
Fistula	4	4
Scarring	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
Cardiac Arrest	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