TPLC - Total Product Life Cycle

• Device: mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
• 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	3

MDR Year	MDR Reports	MDR Events
2019	2455	2455
2020	1004	1004
2021	2606	2606
2022	809	809
2023	1076	1076
2024	797	797

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6201	6201
Migration	1600	1600
Appropriate Term/Code Not Available	496	496
Insufficient Information	182	182
Positioning Problem	81	81
Material Integrity Problem	56	56
Material Erosion	54	54
Detachment of Device or Device Component	42	42
Material Protrusion/Extrusion	33	33
Material Twisted/Bent	32	32
Patient-Device Incompatibility	29	29
Material Split, Cut or Torn	27	27
Patient Device Interaction Problem	21	21
Device Appears to Trigger Rejection	20	20
Defective Device	20	20
Break	19	19
Migration or Expulsion of Device	15	15
Difficult to Advance	14	14
Material Deformation	12	12
Use of Device Problem	11	11
Fracture	9	9
Material Separation	9	9
Therapeutic or Diagnostic Output Failure	7	7
Difficult to Remove	7	7
No Apparent Adverse Event	6	6
Device Dislodged or Dislocated	5	5
Difficult or Delayed Positioning	5	5
Unsealed Device Packaging	5	5
Degraded	4	4
Unraveled Material	4	4
Material Disintegration	4	4
Contamination	3	3
Material Fragmentation	3	3
Inadequacy of Device Shape and/or Size	3	3
Output Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Improper or Incorrect Procedure or Method	3	3
Defective Component	2	2
Delivered as Unsterile Product	2	2
Packaging Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Device Damaged Prior to Use	2	2
Missing Information	2	2
Malposition of Device	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Material Too Rigid or Stiff	1	1
Obstruction of Flow	1	1
Unclear Information	1	1
Material Perforation	1	1
Device Damaged by Another Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	3885	3885
Erosion	2455	2455
Insufficient Information	1556	1556
Incontinence	1520	1520
Injury	1509	1509
Not Applicable	1035	1035
Urinary Tract Infection	936	936
Dyspareunia	882	882
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	604	604
Constipation	596	596
Urinary Retention	587	587
Micturition Urgency	557	557
Unspecified Infection	492	492
Urinary Incontinence	457	457
Urinary Frequency	415	415
Hemorrhage/Bleeding	413	413
No Code Available	413	413
Abnormal Vaginal Discharge	412	412
Inflammation	358	358
Prolapse	347	347
Scar Tissue	304	304
Discomfort	303	303
Unspecified Mental, Emotional or Behavioural Problem	285	285
Abdominal Pain	275	275
Dysuria	250	250
Obstruction/Occlusion	224	224
Hematuria	166	166
Nerve Damage	164	164
Adhesion(s)	160	160
Fatigue	151	151
Depression	150	150
Unspecified Kidney or Urinary Problem	146	146
Unspecified Tissue Injury	130	130
Anxiety	130	130
Cramp(s) /Muscle Spasm(s)	129	129
Burning Sensation	127	127
No Clinical Signs, Symptoms or Conditions	127	127
Blood Loss	101	101
Ambulation Difficulties	101	101
Numbness	100	100
Bacterial Infection	95	95
Fistula	92	92
Hematoma	91	91
Abscess	89	89
Nausea	89	89
Perforation	87	87
Disability	74	74
Fever	72	72
Swelling/ Edema	70	70
Deformity/ Disfigurement	68	68