TPLC - Total Product Life Cycle

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Device	mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
Regulation Description	Surgical mesh.
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	490	490
Break	215	215
Migration	125	125
Appropriate Term/Code Not Available	84	84
Detachment of Device or Device Component	46	46
Device Dislodged or Dislocated	39	39
Insufficient Information	34	34
Device Appears to Trigger Rejection	28	28
Material Split, Cut or Torn	23	23
Material Protrusion/Extrusion	21	21
No Apparent Adverse Event	19	19
Material Twisted/Bent	19	19
Positioning Problem	17	17
Material Erosion	15	15
Material Fragmentation	15	15
Material Deformation	14	14
Migration or Expulsion of Device	10	10
Difficult to Advance	9	9
Defective Device	9	9
Patient Device Interaction Problem	9	9
Material Separation	9	9
Positioning Failure	9	9
Fracture	8	8
Malposition of Device	7	7
Premature Activation	6	6
Improper or Incorrect Procedure or Method	6	6
Material Frayed	5	5
Device Slipped	5	5
Missing Information	5	5
Difficult or Delayed Separation	3	3
Loose or Intermittent Connection	2	2
Unintended System Motion	2	2
Inadequacy of Device Shape and/or Size	2	2
Patient-Device Incompatibility	2	2
Separation Problem	2	2
Difficult or Delayed Positioning	1	1
Delivered as Unsterile Product	1	1
Material Too Rigid or Stiff	1	1
Degraded	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Difficult to Remove	1	1
Deflation Problem	1	1
Product Quality Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Activation Failure	1	1
Defective Component	1	1
Unsealed Device Packaging	1	1
Material Puncture/Hole	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	441	441
Erosion	358	358
No Clinical Signs, Symptoms or Conditions	353	353
Dyspareunia	184	184
Urinary Incontinence	177	177
Urinary Tract Infection	150	150
Incontinence	140	140
Urinary Retention	117	117
Micturition Urgency	115	115
Insufficient Information	100	100
Abnormal Vaginal Discharge	89	89
Dysuria	81	81
Unspecified Infection	78	78
Urinary Frequency	77	77
Scar Tissue	70	70
Inflammation	61	61
Prolapse	61	61
Hematuria	57	57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	56	56
Constipation	53	53
Discomfort	49	49
Hemorrhage/Bleeding	48	48
No Code Available	47	47
Abdominal Pain	39	39
Cramp(s) /Muscle Spasm(s)	38	38
Injury	36	36
Intermenstrual Bleeding	30	30
Bacterial Infection	30	30
Burning Sensation	30	30
Genital Bleeding	27	27
Unspecified Kidney or Urinary Problem	26	26
Foreign Body In Patient	26	26
Unspecified Mental, Emotional or Behavioural Problem	25	25
Deformity/ Disfigurement	25	25
Perforation	22	22
Foreign Body Reaction	21	21
Muscle Weakness	21	21
Obstruction/Occlusion	21	21
Depression	21	21
Nerve Damage	19	19
Sexual Dysfunction	18	18
Fistula	17	17
No Consequences Or Impact To Patient	17	17
Skin Erosion	16	16
Nausea	16	16
Anxiety	16	16
Impaired Healing	15	15
Kidney Infection	15	15
Abscess	14	14
Emotional Changes	14	14