TPLC - Total Product Life Cycle

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Device	mesh, surgical, for stress urinary incontinence, male
Definition	surgical treatment of male stress urinary incontinence post-prostatectomy
Product Code	OTM
Regulation Number	878.3300
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST
	SUBSTANTIALLY EQUIVALENT - KIT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	902	902
Adverse Event Without Identified Device or Use Problem	121	121
Mechanical Problem	40	40
Defective Device	21	21
Break	13	13
Material Split, Cut or Torn	9	9
Malposition of Device	8	8
Premature Activation	7	7
Component Missing	3	3
Use of Device Problem	3	3
Device Dislodged or Dislocated	3	3
Connection Problem	2	2
Fluid/Blood Leak	2	2
Material Frayed	2	2
Unsealed Device Packaging	2	2
Device Contamination with Chemical or Other Material	2	2
Material Twisted/Bent	1	1
Appropriate Term/Code Not Available	1	1
Device Appears to Trigger Rejection	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device Damaged Prior to Use	1	1
Therapeutic or Diagnostic Output Failure	1	1
Difficult to Insert	1	1
Detachment of Device or Device Component	1	1
Migration	1	1
Missing Information	1	1
Inflation Problem	1	1
Packaging Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	426	426
Incontinence	227	227
No Clinical Signs, Symptoms or Conditions	208	208
Urinary Incontinence	178	178
Insufficient Information	56	56
No Consequences Or Impact To Patient	34	34
Pain	25	25
Urinary Retention	13	13
Unspecified Infection	8	8
Erosion	8	8
Wound Dehiscence	5	5
No Code Available	5	5
Hematoma	5	5
Urinary Tract Infection	4	4
Perforation	4	4
Complaint, Ill-Defined	3	3
Device Embedded In Tissue or Plaque	2	2
Hemorrhage/Bleeding	2	2
Scar Tissue	2	2
Micturition Urgency	2	2
Injury	2	2
Foreign Body Reaction	2	2
Hematuria	2	2
Impaired Healing	2	2
Foreign Body In Patient	1	1
Skin Inflammation/ Irritation	1	1
Thrombosis	1	1
Nerve Damage	1	1
No Information	1	1
Disability	1	1
Discomfort	1	1
Emotional Changes	1	1
Pneumonia	1	1
Abscess	1	1
Swelling/ Edema	1	1
Perforation of Vessels	1	1
Unspecified Tissue Injury	1	1
Tissue Damage	1	1
Sepsis	1	1
Nerve Proximity Nos (Not Otherwise Specified)	1	1
Stroke/CVA	1	1
Hypoesthesia	1	1
Bacterial Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Pulmonary Embolism	1	1