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	449	450
Break	328	328
Migration	113	113
Appropriate Term/Code Not Available	72	72
Device Dislodged or Dislocated	43	43
Detachment of Device or Device Component	38	38
Material Fragmentation	30	30
Device Appears to Trigger Rejection	29	29
Material Split, Cut or Torn	28	28
Material Protrusion/Extrusion	21	21
Material Twisted/Bent	21	21
Insufficient Information	19	19
Device Slipped	16	16
Positioning Problem	13	13
Material Erosion	13	13
Difficult to Advance	12	12
No Apparent Adverse Event	12	12
Material Separation	11	11
Material Deformation	10	10
Patient Device Interaction Problem	10	10
Migration or Expulsion of Device	9	9
Positioning Failure	9	9
Malposition of Device	8	8
Defective Device	7	7
Improper or Incorrect Procedure or Method	7	7
Fracture	7	7
Material Frayed	5	5
Premature Activation	4	4
Difficult or Delayed Separation	3	3
Separation Problem	2	2
Unintended System Motion	2	2
Unsealed Device Packaging	1	1
Material Puncture/Hole	1	1
Product Quality Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Difficult to Remove	1	1
Loose or Intermittent Connection	1	1
Nonstandard Device	1	1
Delivered as Unsterile Product	1	1
Deflation Problem	1	1
Difficult or Delayed Positioning	1	1
Defective Component	1	1
Expiration Date Error	1	1
Patient-Device Incompatibility	1	1
Deformation Due to Compressive Stress	1	1
Expulsion	1	1
Device Contaminated During Manufacture or Shipping	1	1
Therapeutic or Diagnostic Output Failure	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Activation Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	511	511
Pain	403	404
Erosion	332	333
Dyspareunia	194	195
Urinary Incontinence	183	184
Urinary Tract Infection	145	145
Micturition Urgency	113	113
Incontinence	108	108
Urinary Retention	108	109
Abnormal Vaginal Discharge	98	99
Insufficient Information	97	97
Dysuria	76	76
Urinary Frequency	72	72
Scar Tissue	69	69
Unspecified Infection	64	64
Inflammation	58	58
Hematuria	58	58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	56	56
Constipation	56	56
Hemorrhage/Bleeding	54	54
Prolapse	54	54
Discomfort	53	53
Cramp(s) /Muscle Spasm(s)	41	41
Abdominal Pain	33	33
Bacterial Infection	33	33
Intermenstrual Bleeding	30	30
Burning Sensation	29	29
Unspecified Kidney or Urinary Problem	29	29
Deformity/ Disfigurement	27	27
Genital Bleeding	27	27
Unspecified Mental, Emotional or Behavioural Problem	26	26
Perforation	26	26
Foreign Body In Patient	25	25
Depression	23	23
Muscle Weakness	22	22
Sexual Dysfunction	22	22
Anxiety	17	17
Impaired Healing	17	17
Fistula	16	16
Abscess	16	16
Skin Erosion	16	16
Kidney Infection	15	16
Adhesion(s)	14	14
Nausea	14	14
Obstruction/Occlusion	14	14
Neuralgia	14	14
Swelling/ Edema	13	13
Skin Inflammation/ Irritation	12	12
Fungal Infection	12	12
Nerve Damage	12	12