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	2
COLOPLAST
	SUBSTANTIALLY EQUIVALENT - KIT	1
COLOPLAST A/S
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	1021	1021
Adverse Event Without Identified Device or Use Problem	220	220
Mechanical Problem	41	41
Defective Device	22	22
Malposition of Device	20	20
Break	15	15
Device Operates Differently Than Expected	12	12
Material Split, Cut or Torn	9	9
Migration or Expulsion of Device	7	7
Premature Activation	7	7
Torn Material	4	4
Use of Device Problem	4	4
Device Dislodged or Dislocated	4	4
Material Frayed	3	3
Component Missing	3	3
Device Contamination with Chemical or Other Material	2	2
Migration	2	2
Unsealed Device Packaging	2	2
Detachment of Device or Device Component	2	2
Difficult to Insert	2	2
Appropriate Term/Code Not Available	2	2
Connection Problem	2	2
Unexpected Therapeutic Results	2	2
Fluid/Blood Leak	2	2
Improper or Incorrect Procedure or Method	1	1
Missing Information	1	1
Other (for use when an appropriate device code cannot be identified)	1	1
Shelf Life Exceeded	1	1
Device Inoperable	1	1
Device Appears to Trigger Rejection	1	1
Device Or Device Fragments Location Unknown	1	1
Inflation Problem	1	1
Material Rupture	1	1
Packaging Problem	1	1
Material Twisted/Bent	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Integrity Problem	1	1
Patient-Device Incompatibility	1	1
Device Damaged Prior to Use	1	1
Extrusion	1	1
Device Contaminated During Manufacture or Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	487	487
Incontinence	361	361
No Clinical Signs, Symptoms or Conditions	208	208
Urinary Incontinence	178	178
Insufficient Information	56	56
Pain	52	52
No Consequences Or Impact To Patient	36	36
Urinary Retention	33	33
Erosion	30	30
Unspecified Infection	16	16
Injury	16	16
No Code Available	8	8
Perforation	8	8
Urinary Tract Infection	7	7
No Information	7	7
Death	6	6
Complaint, Ill-Defined	5	5
Wound Dehiscence	5	5
Emotional Changes	5	5
Hematoma	5	5
Discomfort	5	5
Internal Organ Perforation	4	4
Failure of Implant	4	4
Discharge	4	4
Foreign Body In Patient	4	4
Fistula	3	3
Hematuria	3	3
Abscess	3	3
Micturition Urgency	3	3
Device Embedded In Tissue or Plaque	2	2
Hemorrhage/Bleeding	2	2
Tissue Damage	2	2
Scar Tissue	2	2
Prolapse	2	2
Numbness	2	2
Foreign Body Reaction	2	2
Blood Loss	2	2
Scarring	2	2
Disability	2	2
Sepsis	2	2
Impaired Healing	2	2
Burning Sensation	1	1
Fever	1	1
Neurological Deficit/Dysfunction	1	1
Atrial Fibrillation	1	1
Surgical procedure	1	1
Muscle Spasm(s)	1	1
Thrombosis	1	1
Nerve Damage	1	1
Other (for use when an appropriate patient code cannot be identified)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American Medical Systems, Inc.	II	Dec-16-2014