TPLC - Total Product Life Cycle

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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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6089	6089
Migration	1578	1578
Appropriate Term/Code Not Available	484	484
Insufficient Information	181	181
Positioning Problem	81	81
Material Integrity Problem	55	55
Material Erosion	54	54
Detachment of Device or Device Component	41	41
Material Protrusion/Extrusion	33	33
Material Twisted/Bent	30	30
Patient-Device Incompatibility	29	29
Material Split, Cut or Torn	25	25
Patient Device Interaction Problem	21	21
Defective Device	20	20
Device Appears to Trigger Rejection	18	18
Migration or Expulsion of Device	15	15
Break	13	13
Difficult to Advance	13	13
Material Deformation	12	12
Use of Device Problem	10	10
Material Separation	9	9
Fracture	9	9
Difficult to Remove	7	7
Therapeutic or Diagnostic Output Failure	7	7
No Apparent Adverse Event	6	6
Difficult or Delayed Positioning	5	5
Unsealed Device Packaging	5	5
Device Dislodged or Dislocated	5	5
Material Disintegration	4	4
Unraveled Material	4	4
Degraded	4	4
Improper or Incorrect Procedure or Method	3	3
Device Contaminated During Manufacture or Shipping	3	3
Output Problem	3	3
Material Fragmentation	3	3
Contamination	3	3
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
Defective Component	2	2
Packaging Problem	2	2
Delivered as Unsterile Product	2	2
Loose or Intermittent Connection	1	1
Device-Device Incompatibility	1	1
Material Frayed	1	1
Crack	1	1
Device Markings/Labelling Problem	1	1
Peeled/Delaminated	1	1
Calcified	1	1
Unclear Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	3790	3790
Erosion	2389	2389
Insufficient Information	1550	1550
Injury	1509	1509
Incontinence	1504	1504
Not Applicable	1035	1035
Urinary Tract Infection	910	910
Dyspareunia	861	861
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	594	594
Constipation	593	593
Urinary Retention	567	567
Micturition Urgency	545	545
Unspecified Infection	465	465
Urinary Incontinence	429	429
No Code Available	413	413
Urinary Frequency	401	401
Hemorrhage/Bleeding	398	398
Abnormal Vaginal Discharge	398	398
Inflammation	346	346
Prolapse	337	337
Scar Tissue	297	297
Discomfort	296	296
Unspecified Mental, Emotional or Behavioural Problem	276	276
Abdominal Pain	271	271
Dysuria	244	244
Obstruction/Occlusion	221	221
Nerve Damage	161	161
Hematuria	158	158
Adhesion(s)	154	154
Fatigue	147	147
Depression	146	146
Unspecified Kidney or Urinary Problem	138	138
Anxiety	130	130
Unspecified Tissue Injury	125	125
Burning Sensation	124	124
Cramp(s) /Muscle Spasm(s)	123	123
No Clinical Signs, Symptoms or Conditions	117	117
Blood Loss	101	101
Numbness	97	97
Bacterial Infection	94	94
Ambulation Difficulties	91	91
Abscess	89	89
Hematoma	88	88
Nausea	87	87
Fistula	85	85
Perforation	84	84
Disability	74	74
Fever	70	70
Swelling/ Edema	68	68
Deformity/ Disfigurement	66	66