TPLC - Total Product Life Cycle

show TPLC since

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	475	475
Break	196	196
Migration	125	125
Appropriate Term/Code Not Available	84	84
Detachment of Device or Device Component	46	46
Device Dislodged or Dislocated	36	36
Insufficient Information	34	34
Device Appears to Trigger Rejection	25	25
Material Split, Cut or Torn	22	22
Material Protrusion/Extrusion	21	21
No Apparent Adverse Event	19	19
Material Twisted/Bent	19	19
Positioning Problem	17	17
Material Erosion	14	14
Material Deformation	14	14
Material Fragmentation	13	13
Migration or Expulsion of Device	10	10
Difficult to Advance	9	9
Defective Device	9	9
Patient Device Interaction Problem	9	9
Positioning Failure	9	9
Fracture	8	8
Material Separation	8	8
Malposition of Device	7	7
Premature Activation	6	6
Improper or Incorrect Procedure or Method	6	6
Material Frayed	5	5
Missing Information	5	5
Device Slipped	4	4
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	430	430
Erosion	346	346
No Clinical Signs, Symptoms or Conditions	330	330
Dyspareunia	177	177
Urinary Incontinence	170	170
Urinary Tract Infection	143	143
Incontinence	138	138
Micturition Urgency	112	112
Urinary Retention	110	110
Insufficient Information	100	100
Abnormal Vaginal Discharge	84	84
Dysuria	80	80
Unspecified Infection	76	76
Urinary Frequency	76	76
Scar Tissue	65	65
Prolapse	61	61
Inflammation	59	59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	56	56
Constipation	51	51
Hematuria	51	51
Discomfort	48	48
No Code Available	47	47
Hemorrhage/Bleeding	44	44
Abdominal Pain	38	38
Injury	36	36
Cramp(s) /Muscle Spasm(s)	35	35
Bacterial Infection	29	29
Burning Sensation	29	29
Intermenstrual Bleeding	28	28
Genital Bleeding	27	27
Unspecified Kidney or Urinary Problem	24	24
Foreign Body In Patient	23	23
Deformity/ Disfigurement	22	22
Muscle Weakness	21	21
Foreign Body Reaction	21	21
Unspecified Mental, Emotional or Behavioural Problem	21	21
Depression	21	21
Perforation	20	20
Obstruction/Occlusion	20	20
Nerve Damage	19	19
Sexual Dysfunction	18	18
No Consequences Or Impact To Patient	17	17
Fistula	17	17
Anxiety	16	16
Skin Erosion	16	16
Nausea	16	16
Impaired Healing	15	15
Abscess	14	14
Emotional Changes	14	14
Kidney Infection	14	14