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
Device Dislodged or Dislocated	4	4
Torn Material	4	4
Use of Device Problem	4	4
Material Frayed	3	3
Component Missing	3	3
Appropriate Term/Code Not Available	2	2
Unsealed Device Packaging	2	2
Difficult to Insert	2	2
Migration	2	2
Detachment of Device or Device Component	2	2
Device Contamination with Chemical or Other Material	2	2
Unexpected Therapeutic Results	2	2
Connection Problem	2	2
Fluid/Blood Leak	2	2
Device Inoperable	1	1
Material Rupture	1	1
Inflation Problem	1	1
Packaging Problem	1	1
Material Twisted/Bent	1	1
Improper or Incorrect Procedure or Method	1	1
Device Appears to Trigger Rejection	1	1
Device Or Device Fragments Location Unknown	1	1
Other (for use when an appropriate device code cannot be identified)	1	1
Missing Information	1	1
Shelf Life Exceeded	1	1
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	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
Perforation	8	8
No Code Available	8	8
No Information	7	7
Urinary Tract Infection	7	7
Death	6	6
Emotional Changes	5	5
Hematoma	5	5
Complaint, Ill-Defined	5	5
Wound Dehiscence	5	5
Discomfort	5	5
Internal Organ Perforation	4	4
Failure of Implant	4	4
Foreign Body In Patient	4	4
Discharge	4	4
Hematuria	3	3
Fistula	3	3
Micturition Urgency	3	3
Abscess	3	3
Sepsis	2	2
Disability	2	2
Scarring	2	2
Blood Loss	2	2
Hemorrhage/Bleeding	2	2
Foreign Body Reaction	2	2
Numbness	2	2
Tissue Damage	2	2
Device Embedded In Tissue or Plaque	2	2
Impaired Healing	2	2
Scar Tissue	2	2
Prolapse	2	2
Fibrosis	1	1
Hypoesthesia	1	1
Urinary Frequency	1	1
Bacterial Infection	1	1
Pulmonary Embolism	1	1
Therapeutic Response, Decreased	1	1
Distress	1	1
Swelling/ Edema	1	1
Unspecified Tissue Injury	1	1

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