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
AMERICAN MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
AMERICAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ATHENA SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CALDERA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
CALDERA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	6
COLOPLAST A/S
	SUBSTANTIALLY EQUIVALENT	1
ETHICON INC.
	SUBSTANTIALLY EQUIVALENT	1
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	3
GENERIC MEDICAL DEVICE, INC.
	SUBSTANTIALLY EQUIVALENT	2
GENERIC MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MPATHY MEDICAL DEVICES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEOMEDIC INTERNATIONAL S.L.
	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	7782	7782
Appropriate Term/Code Not Available	2535	2535
Migration or Expulsion of Device	1978	1978
Migration	1674	1674
Insufficient Information	1570	1570
Material Erosion	1104	1104
Other (for use when an appropriate device code cannot be identified)	777	777
Extrusion	152	152
Break	95	95
Positioning Problem	84	84
Device Operates Differently Than Expected	72	72
Patient-Device Incompatibility	69	69
Material Integrity Problem	59	59
Material Protrusion/Extrusion	50	50
Detachment of Device or Device Component	49	49
Material Twisted/Bent	42	42
Material Split, Cut or Torn	31	31
Difficult to Advance	29	29
Detachment Of Device Component	29	29
Material Deformation	25	25
Defective Device	24	24
Torn Material	22	22
No Apparent Adverse Event	22	22
Patient Device Interaction Problem	22	22
Device Appears to Trigger Rejection	19	19
Malposition of Device	16	16
Difficult to Remove	16	16
Material Separation	15	15
Use of Device Problem	12	12
Improper or Incorrect Procedure or Method	11	11
Therapeutic or Diagnostic Output Failure	11	11
Device Dislodged or Dislocated	10	10
Fracture	9	9
Material Frayed	9	9
Unsealed Device Packaging	9	9
Material Fragmentation	9	9
Hole In Material	8	8
Material Perforation	7	7
Separation Failure	7	7
Degraded	7	7
Tear, Rip or Hole in Device Packaging	6	6
Bent	6	6
Sticking	6	6
Difficult or Delayed Positioning	6	6
Device Packaging Compromised	5	5
Material Rupture	4	4
Unknown (for use when the device problem is not known)	4	4
Folded	4	4
Implant extrusion	4	4
Material Disintegration	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	7379	7380
Erosion	5831	5831
No Code Available	4011	4011
Incontinence	2813	2813
Injury	2296	2296
Insufficient Information	1566	1566
Not Applicable	1455	1455
Urinary Tract Infection	1410	1410
Unspecified Infection	1213	1213
Other (for use when an appropriate patient code cannot be identified)	1005	1005
Surgical procedure	980	980
Urinary Retention	928	928
Dyspareunia	862	862
Micturition Urgency	804	804
Urinary Frequency	666	667
Constipation	632	632
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	597	597
Inflammation	506	506
Abnormal Vaginal Discharge	486	486
Prolapse	484	484
No Information	467	467
Hemorrhage/Bleeding	455	456
Scar Tissue	451	451
Urinary Incontinence	432	432
Discomfort	418	418
Blood Loss	366	366
Death	363	363
Dysuria	344	344
Abdominal Pain	339	339
Obstruction/Occlusion	298	298
Hematuria	283	283
Unspecified Mental, Emotional or Behavioural Problem	276	276
Nerve Damage	232	232
Adhesion(s)	231	231
No Consequences Or Impact To Patient	219	219
Burning Sensation	190	190
Fatigue	189	189
Emotional Changes	189	189
Scarring	172	172
Depression	170	170
Ambulation Difficulties	163	163
Fistula	162	162
Anxiety	151	151
Perforation	141	141
Unspecified Kidney or Urinary Problem	138	138
Internal Organ Perforation	133	133
Unspecified Tissue Injury	130	130
Cramp(s) /Muscle Spasm(s)	126	126
Hematoma	126	126
Disability	126	126

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