TPLC - Total Product Life Cycle

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Device	mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
Definition	Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Product Code	PAH
Regulation Number	878.3300
Device Class	2

Premarket Reviews
Manufacturer	Decision
AMERICAN MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
AMERICAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
CALDERA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
COLOPLAST A/S
	SUBSTANTIALLY EQUIVALENT	2
MPATHY MEDICAL DEVICES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PROMEDON S.A.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1072	1072
Insufficient Information	624	624
Break	184	184
Material Erosion	182	182
Migration	160	160
Appropriate Term/Code Not Available	130	130
Migration or Expulsion of Device	88	88
Extrusion	68	68
Material Protrusion/Extrusion	52	52
Device Operates Differently Than Expected	48	48
Detachment of Device or Device Component	47	47
Positioning Failure	42	42
Device Dislodged or Dislocated	38	38
Patient-Device Incompatibility	38	38
Material Twisted/Bent	30	30
Positioning Problem	28	28
Device Appears to Trigger Rejection	27	27
Other (for use when an appropriate device code cannot be identified)	24	24
No Apparent Adverse Event	19	19
Detachment Of Device Component	18	18
Material Deformation	18	18
Malposition of Device	16	16
Bent	13	13
Defective Device	12	12
Material Split, Cut or Torn	12	12
Difficult to Advance	11	11
Material Fragmentation	11	11
Premature Activation	10	10
Fracture	9	9
Patient Device Interaction Problem	7	7
Loose or Intermittent Connection	7	7
Therapeutic or Diagnostic Output Failure	6	6
Torn Material	6	6
Missing Information	6	6
Material Separation	6	6
Improper or Incorrect Procedure or Method	5	5
Unexpected Therapeutic Results	5	5
Device Slipped	4	4
Unintended Movement	4	4
Material Frayed	4	4
Difficult To Position	4	4
Deformation Due to Compressive Stress	3	3
Difficult to Remove	3	3
Device Or Device Fragments Location Unknown	3	3
Leak/Splash	3	3
Difficult or Delayed Separation	3	3
Activation, Positioning or Separation Problem	2	2
Defective Component	2	2
Disconnection	2	2
Component Falling	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	1245	1245
Erosion	716	716
Incontinence	578	578
Injury	427	427
Urinary Tract Infection	296	296
Urinary Retention	285	285
Unspecified Infection	276	276
No Code Available	226	226
Micturition Urgency	209	209
No Clinical Signs, Symptoms or Conditions	209	209
Dysuria	160	160
Dyspareunia	159	159
Urinary Frequency	151	151
Urinary Incontinence	150	150
Hemorrhage/Bleeding	132	132
No Information	127	127
Prolapse	126	126
Surgical procedure	103	103
Insufficient Information	101	101
Death	99	99
Discomfort	97	97
Abnormal Vaginal Discharge	96	96
Scar Tissue	96	96
Inflammation	91	91
Scarring	86	86
Abdominal Pain	85	85
No Consequences Or Impact To Patient	84	84
Emotional Changes	81	81
No Known Impact Or Consequence To Patient	80	80
Hematuria	78	78
Not Applicable	77	77
Blood Loss	66	66
Constipation	63	63
Other (for use when an appropriate patient code cannot be identified)	61	61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	56	56
Burning Sensation	48	48
Foreign Body Reaction	47	47
Complaint, Ill-Defined	47	47
Obstruction/Occlusion	41	41
Internal Organ Perforation	40	40
Perforation	39	39
Intermenstrual Bleeding	37	37
Bacterial Infection	34	34
Tissue Damage	33	33
Fistula	33	33
Foreign Body In Patient	31	31
Nerve Damage	31	31
Cramp(s) /Muscle Spasm(s)	30	30
Laceration(s)	29	29
Nausea	28	28

Recalls
Manufacturer		Recall Class	Date Posted
1	Astora	II	Nov-16-2015