TPLC - Total Product Life Cycle

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Device	mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Regulation Description	Surgical mesh.
Definition	Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
Product Code	OTN
Regulation Number	878.3300
Device Class	2

Premarket Reviews
Manufacturer	Decision
ATHENA SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
CALDERA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ETHICON INC.
	SUBSTANTIALLY EQUIVALENT	1
UROCURE LLC
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4400	4400
Migration	1244	1244
Appropriate Term/Code Not Available	500	500
Insufficient Information	101	101
Positioning Problem	81	81
Material Integrity Problem	54	54
Material Erosion	44	44
Detachment of Device or Device Component	40	40
Material Protrusion/Extrusion	28	28
Material Twisted/Bent	28	28
Material Split, Cut or Torn	24	24
Patient Device Interaction Problem	22	22
Device Appears to Trigger Rejection	20	20
Defective Device	18	18
Break	14	14
Migration or Expulsion of Device	13	13
Difficult to Advance	12	12
Fracture	11	11
Patient-Device Incompatibility	10	10
Use of Device Problem	10	10
Material Deformation	9	9
Unsealed Device Packaging	9	9
Material Separation	7	7
Difficult to Remove	6	6
Device Dislodged or Dislocated	5	5
Difficult or Delayed Positioning	5	5
Therapeutic or Diagnostic Output Failure	5	5
No Apparent Adverse Event	4	4
Unraveled Material	4	4
Degraded	4	4
Material Disintegration	4	4
Device Contaminated During Manufacture or Shipping	4	4
Contamination	3	3
Delivered as Unsterile Product	3	3
Output Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Material Fragmentation	2	2
Defective Component	2	2
Device Damaged Prior to Use	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Contamination with Chemical or Other Material	2	2
Malposition of Device	2	2
Missing Information	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Unclear Information	1	1
Obstruction of Flow	1	1
Device Markings/Labelling Problem	1	1
Crack	1	1
Material Rupture	1	1
Electromagnetic Compatibility Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	3292	3292
Erosion	2040	2040
Insufficient Information	1576	1576
Incontinence	1291	1291
Dyspareunia	914	914
Urinary Tract Infection	797	797
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	606	606
Constipation	588	588
Micturition Urgency	512	512
Urinary Retention	504	504
Urinary Incontinence	475	475
Unspecified Infection	433	433
Abnormal Vaginal Discharge	413	413
Hemorrhage/Bleeding	407	407
Urinary Frequency	373	373
Inflammation	333	333
Prolapse	330	330
Injury	325	325
Unspecified Mental, Emotional or Behavioural Problem	320	320
Scar Tissue	309	309
No Code Available	291	291
Discomfort	277	277
Abdominal Pain	260	260
Not Applicable	238	238
Dysuria	235	235
Obstruction/Occlusion	191	191
Unspecified Kidney or Urinary Problem	177	177
Nerve Damage	154	154
Hematuria	150	150
No Clinical Signs, Symptoms or Conditions	147	147
Unspecified Tissue Injury	142	142
Depression	139	139
Adhesion(s)	137	137
Cramp(s) /Muscle Spasm(s)	131	131
Burning Sensation	124	124
Anxiety	121	121
Fatigue	115	115
Ambulation Difficulties	95	95
Numbness	93	93
Bacterial Infection	93	93
Fistula	85	85
Nausea	84	84
Deformity/ Disfigurement	78	78
Abscess	78	78
Perforation	77	77
Hematoma	73	73
Swelling/ Edema	72	72
Muscle Weakness	66	66
Fever	64	64
Diarrhea	58	58