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
UROCURE, LLC
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3862	3876
Migration	1027	1030
Appropriate Term/Code Not Available	475	477
Positioning Problem	78	78
Insufficient Information	76	76
Material Integrity Problem	51	51
Detachment of Device or Device Component	41	41
Material Erosion	40	40
Manufacturing, Packaging or Shipping Problem	36	36
Material Twisted/Bent	26	26
Material Split, Cut or Torn	25	25
Material Protrusion/Extrusion	25	25
Patient Device Interaction Problem	17	17
Device Appears to Trigger Rejection	16	16
Difficult to Advance	15	15
Break	14	14
Migration or Expulsion of Device	13	13
Defective Device	13	13
Unsealed Device Packaging	11	11
Fracture	9	9
Use of Device Problem	9	9
Patient-Device Incompatibility	7	7
Material Deformation	6	6
No Apparent Adverse Event	5	5
Difficult or Delayed Positioning	5	5
Device Dislodged or Dislocated	4	4
Difficult to Remove	4	4
Therapeutic or Diagnostic Output Failure	4	4
Material Disintegration	4	4
Malposition of Device	4	4
Device Contaminated During Manufacture or Shipping	4	4
Contamination	3	3
Degraded	3	3
Shipping Damage or Problem	3	3
Unraveled Material	3	3
Delivered as Unsterile Product	3	3
Material Separation	3	3
Output Problem	3	3
Material Fragmentation	2	2
Packaging Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Improper or Incorrect Procedure or Method	2	2
Defective Component	1	1
Obstruction of Flow	1	1
Device Damaged Prior to Use	1	1
Off-Label Use	1	1
Material Rupture	1	1
Electromagnetic Compatibility Problem	1	1
Mechanical Problem	1	1
Entrapment of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	2869	2883
Erosion	1734	1740
Insufficient Information	1616	1619
Incontinence	1116	1116
Dyspareunia	912	914
Urinary Tract Infection	696	697
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	580	585
Constipation	568	568
Urinary Incontinence	501	503
Micturition Urgency	462	462
Urinary Retention	458	459
Abnormal Vaginal Discharge	396	399
Hemorrhage/Bleeding	378	379
Unspecified Infection	368	371
Urinary Frequency	333	333
Unspecified Mental, Emotional or Behavioural Problem	331	331
Scar Tissue	299	299
Inflammation	293	294
Prolapse	286	287
Discomfort	260	260
Dysuria	218	219
Abdominal Pain	217	218
No Clinical Signs, Symptoms or Conditions	189	189
Unspecified Kidney or Urinary Problem	179	179
Obstruction/Occlusion	168	169
Unspecified Tissue Injury	138	138
Adhesion(s)	131	131
Depression	126	126
Nerve Damage	124	124
Hematuria	123	125
Cramp(s) /Muscle Spasm(s)	120	120
Anxiety	110	110
Burning Sensation	106	106
Fatigue	100	100
Ambulation Difficulties	94	94
Bacterial Infection	82	82
Numbness	78	78
Fistula	73	73
Perforation	71	71
Abscess	71	71
Nausea	71	72
Deformity/ Disfigurement	71	71
Swelling/ Edema	66	66
Hematoma	63	63
Injury	59	59
Muscle Weakness	56	56
Fever	55	56
Diarrhea	49	49
Genital Bleeding	47	47
Vomiting	45	46