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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	612	612
Migration	150	150
Break	118	118
Insufficient Information	87	87
Appropriate Term/Code Not Available	82	82
Detachment of Device or Device Component	46	46
Device Dislodged or Dislocated	29	29
Material Protrusion/Extrusion	28	28
Material Twisted/Bent	25	25
Device Appears to Trigger Rejection	25	25
No Apparent Adverse Event	19	19
Positioning Failure	17	17
Positioning Problem	17	17
Material Deformation	16	16
Material Erosion	15	15
Material Split, Cut or Torn	12	12
Migration or Expulsion of Device	11	11
Difficult to Advance	11	11
Material Fragmentation	10	10
Defective Device	10	10
Fracture	8	8
Patient Device Interaction Problem	7	7
Premature Activation	7	7
Patient-Device Incompatibility	7	7
Missing Information	6	6
Material Separation	4	4
Material Frayed	4	4
Loose or Intermittent Connection	3	3
Malposition of Device	3	3
Difficult or Delayed Separation	3	3
Inadequacy of Device Shape and/or Size	2	2
Improper or Incorrect Procedure or Method	2	2
Difficult to Remove	2	2
Device Slipped	2	2
Separation Problem	2	2
Activation Failure	1	1
Therapeutic or Diagnostic Output Failure	1	1
Defective Component	1	1
Unsealed Device Packaging	1	1
Human-Device Interface Problem	1	1
Deformation Due to Compressive Stress	1	1
Device Contaminated During Manufacture or Shipping	1	1
Unstable	1	1
Activation, Positioning or Separation Problem	1	1
Mechanical Problem	1	1
Leak/Splash	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Deflation Problem	1	1
Degraded	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	494	494
Erosion	361	361
No Clinical Signs, Symptoms or Conditions	209	209
Incontinence	190	190
Injury	168	168
Dyspareunia	158	158
Urinary Incontinence	148	148
Urinary Tract Infection	143	143
Urinary Retention	117	117
Micturition Urgency	115	115
Insufficient Information	101	101
Unspecified Infection	78	78
Dysuria	77	77
Urinary Frequency	72	72
No Code Available	69	69
Abnormal Vaginal Discharge	68	68
Scar Tissue	66	66
Prolapse	65	65
Inflammation	59	59
Not Applicable	57	57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	55	55
Constipation	50	50
Discomfort	49	49
Hematuria	47	47
Abdominal Pain	38	38
No Consequences Or Impact To Patient	36	36
Hemorrhage/Bleeding	34	34
Foreign Body Reaction	34	34
Intermenstrual Bleeding	33	33
Cramp(s) /Muscle Spasm(s)	30	30
Bacterial Infection	29	29
Burning Sensation	29	29
Genital Bleeding	27	27
No Information	24	24
Depression	21	21
Obstruction/Occlusion	21	21
Unspecified Kidney or Urinary Problem	21	21
Nerve Damage	19	19
Perforation	19	19
Muscle Weakness	19	19
Foreign Body In Patient	18	18
Anxiety	17	17
Nausea	17	17
Adhesion(s)	16	16
Unspecified Mental, Emotional or Behavioural Problem	16	16
Skin Erosion	16	16
Deformity/ Disfigurement	16	16
Kidney Infection	14	14
Fistula	14	14
Sexual Dysfunction	14	14