TPLC - Total Product Life Cycle

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Device	mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
Definition	Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally
Product Code	OTP
Regulation Number	884.5980
Device Class	3

Premarket Reviews
Manufacturer	Decision
AMERICAN MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
AMERICAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BOSTONSCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CALDERA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST A/S
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST CORP.
	SUBSTANTIALLY EQUIVALENT	1
MPATHY MEDICAL DEVICES INC
	SUBSTANTIALLY EQUIVALENT	1
NEOMEDIC INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1745	1745
Detachment Of Device Component	419	419
Insufficient Information	341	341
Migration	278	278
Material Erosion	268	268
Appropriate Term/Code Not Available	166	166
Break	154	154
Detachment of Device or Device Component	145	145
Migration or Expulsion of Device	142	142
Extrusion	120	120
Other (for use when an appropriate device code cannot be identified)	77	77
Retraction Problem	42	42
Patient-Device Incompatibility	27	27
Material Protrusion/Extrusion	24	24
Use of Device Problem	17	17
Defective Device	16	16
Patient Device Interaction Problem	14	14
Device Operates Differently Than Expected	13	13
Material Separation	10	10
Torn Material	9	9
Positioning Problem	8	8
Malposition of Device	8	8
Material Split, Cut or Torn	8	8
Material Deformation	7	7
Material Twisted/Bent	6	6
Material Integrity Problem	6	6
Device Or Device Fragments Location Unknown	4	4
Misfire	4	4
Device Packaging Compromised	3	3
Difficult to Remove	3	3
Defective Component	3	3
Material Rupture	3	3
Degraded	3	3
Device-Device Incompatibility	2	2
Entrapment of Device	2	2
Missing Value Reason	2	2
Therapeutic or Diagnostic Output Failure	2	2
Folded	2	2
Material Disintegration	2	2
Unexpected Therapeutic Results	2	2
Device Slipped	1	1
Disconnection	1	1
Material Frayed	1	1
Failure to Advance	1	1
Fire	1	1
Protective Measures Problem	1	1
Mechanical Problem	1	1
Device Dislodged or Dislocated	1	1
No Apparent Adverse Event	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	1633	1634
Erosion	1207	1208
Incontinence	718	718
No Consequences Or Impact To Patient	387	387
Injury	383	383
Unspecified Infection	365	366
Urinary Tract Infection	350	351
Prolapse	290	291
Constipation	263	264
Dyspareunia	259	259
No Code Available	256	256
Death	245	245
Surgical procedure	237	237
No Known Impact Or Consequence To Patient	230	230
Not Applicable	206	206
Urinary Retention	205	205
No Information	203	203
Abnormal Vaginal Discharge	192	192
Insufficient Information	176	176
Device Embedded In Tissue or Plaque	171	171
Urinary Frequency	169	170
Micturition Urgency	159	160
Blood Loss	156	156
Other (for use when an appropriate patient code cannot be identified)	155	155
Hemorrhage/Bleeding	124	124
Discomfort	122	122
Scar Tissue	115	115
Emotional Changes	112	113
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	109	109
Inflammation	106	107
Dysuria	97	98
Unspecified Mental, Emotional or Behavioural Problem	94	94
Scarring	90	90
Abdominal Pain	81	81
Adhesion(s)	70	70
Fistula	64	64
Hematuria	56	57
Hematoma	54	54
Disability	54	54
Urinary Incontinence	54	54
Obstruction/Occlusion	49	49
Bleeding	45	45
Burning Sensation	40	40
Discharge	39	39
Internal Organ Perforation	39	39
Unspecified Tissue Injury	36	36
Nerve Damage	35	35
Depression	30	30
Neurological Deficit/Dysfunction	29	29
Hernia	28	28