TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2014	72	72
2015	42	42
2016	26	26
2017	16	16
2018	111	111
2019	406	406
2020	261	261
2021	213	213
2022	199	199
2023	28	28
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	1017	1017
Adverse Event Without Identified Device or Use Problem	215	215
Mechanical Problem	39	39
Defective Device	22	22
Malposition of Device	19	19
Break	15	15
Device Operates Differently Than Expected	12	12
Material Split, Cut or Torn	9	9
Premature Activation	7	7
Migration or Expulsion of Device	7	7
Use of Device Problem	4	4
Device Dislodged or Dislocated	4	4
Torn Material	4	4
Component Missing	3	3
Material Frayed	3	3
Fluid/Blood Leak	2	2
Unsealed Device Packaging	2	2
Unexpected Therapeutic Results	2	2
Difficult to Insert	2	2
Connection Problem	2	2
Detachment of Device or Device Component	2	2
Device Contamination with Chemical or Other Material	2	2
Appropriate Term/Code Not Available	2	2
Migration	2	2
Missing Information	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Integrity Problem	1	1
Material Twisted/Bent	1	1
Extrusion	1	1
Packaging Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Patient-Device Incompatibility	1	1
Device Or Device Fragments Location Unknown	1	1
Device Inoperable	1	1
Improper or Incorrect Procedure or Method	1	1
Other (for use when an appropriate device code cannot be identified)	1	1
Device Damaged Prior to Use	1	1
Inflation Problem	1	1
Device Appears to Trigger Rejection	1	1
Material Rupture	1	1
Shelf Life Exceeded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	487	487
Incontinence	360	360
No Clinical Signs, Symptoms or Conditions	205	205
Urinary Incontinence	169	169
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
Emotional Changes	5	5
Hematoma	5	5
Wound Dehiscence	5	5
Discomfort	5	5
Complaint, Ill-Defined	5	5
Discharge	4	4
Foreign Body In Patient	4	4
Failure of Implant	4	4
Internal Organ Perforation	4	4
Micturition Urgency	3	3
Fistula	3	3
Abscess	3	3
Hematuria	3	3
Blood Loss	2	2
Device Embedded In Tissue or Plaque	2	2
Disability	2	2
Impaired Healing	2	2
Numbness	2	2
Prolapse	2	2
Foreign Body Reaction	2	2
Hemorrhage/Bleeding	2	2
Tissue Damage	2	2
Scar Tissue	2	2
Scarring	2	2
Sepsis	2	2
Thrombosis	1	1
Inflammation	1	1
Muscle Spasm(s)	1	1
Nerve Damage	1	1
Neurological Deficit/Dysfunction	1	1
Pneumonia	1	1
Perforation of Vessels	1	1
Burning Sensation	1	1
Tingling	1	1
Fever	1	1
Atrial Fibrillation	1	1
Bacterial Infection	1	1
Bleeding	1	1
Pulmonary Embolism	1	1
Stroke/CVA	1	1
Shaking/Tremors	1	1
Collapse	1	1
Reaction	1	1
Hypoesthesia	1	1
Surgical procedure	1	1
Therapeutic Response, Decreased	1	1
Urinary Frequency	1	1
Distress	1	1
Other (for use when an appropriate patient code cannot be identified)	1	1
Fibrosis	1	1
Weight Changes	1	1
Nerve Proximity Nos (Not Otherwise Specified)	1	1
Dysuria	1	1
Skin Inflammation/ Irritation	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

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