TPLC - Total Product Life Cycle

• Device: mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
• Definition: Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally
• Product Code: OTP
• Regulation Number: 884.5980
• Device Class: 3

MDR Year	MDR Reports	MDR Events
2019	368	368
2020	175	175
2021	647	647
2022	115	115
2023	59	59
2024	16	16

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	952	952
Migration	265	265
Appropriate Term/Code Not Available	89	89
Detachment of Device or Device Component	58	58
Material Erosion	18	18
Defective Device	13	13
Patient Device Interaction Problem	13	13
Use of Device Problem	10	10
Insufficient Information	9	9
Material Protrusion/Extrusion	8	8
Positioning Problem	7	7
Material Split, Cut or Torn	7	7
Material Twisted/Bent	6	6
Patient-Device Incompatibility	6	6
Material Integrity Problem	6	6
Material Deformation	4	4
Migration or Expulsion of Device	4	4
Retraction Problem	3	3
Material Separation	3	3
Device-Device Incompatibility	2	2
Defective Component	1	1
Unexpected Therapeutic Results	1	1
Device Appears to Trigger Rejection	1	1
Calcified	1	1
Contamination	1	1
Degraded	1	1
Difficult or Delayed Positioning	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	791	791
Erosion	526	526
Incontinence	368	368
Dyspareunia	256	256
Injury	248	248
Constipation	233	233
Insufficient Information	169	169
Abnormal Vaginal Discharge	148	148
Prolapse	129	129
Urinary Tract Infection	125	125
Not Applicable	109	109
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	108	108
Unspecified Mental, Emotional or Behavioural Problem	94	94
No Code Available	91	91
Hemorrhage/Bleeding	90	90
Unspecified Infection	78	78
Micturition Urgency	69	69
Discomfort	62	62
Urinary Frequency	61	61
Urinary Incontinence	53	53
Abdominal Pain	51	51
Scar Tissue	48	48
Urinary Retention	47	47
Inflammation	45	45
No Consequences Or Impact To Patient	41	41
Adhesion(s)	36	36
Disability	35	35
Unspecified Tissue Injury	35	35
Dysuria	32	32
Blood Loss	32	32
Hematuria	28	28
Obstruction/Occlusion	27	27
Fistula	25	25
Depression	23	23
Cramp(s) /Muscle Spasm(s)	23	23
Anxiety	22	22
No Known Impact Or Consequence To Patient	18	18
High Blood Pressure/ Hypertension	16	16
Nausea	16	16
Nerve Damage	16	16
Fatigue	14	14
Fibrosis	14	14
Hernia	13	13
Bacterial Infection	13	13
Diarrhea	12	12
Burning Sensation	11	11
Fever	10	10
Perforation	9	9
Scarring	9	9
Itching Sensation	9	9
Discharge	9	9
Vomiting	8	8
Numbness	8	8
Fungal Infection	8	8
Device Embedded In Tissue or Plaque	8	8
Hematoma	8	8
Cyst(s)	8	8
Abscess	8	8
Asthma	8	8
Swelling/ Edema	8	8
Fecal Incontinence	7	7
Purulent Discharge	7	7
Sleep Dysfunction	7	7
Intermenstrual Bleeding	7	7
Bowel Perforation	7	7
Arthralgia	7	7
Distress	7	7
Abdominal Distention	6	6
No Information	6	6
Emotional Changes	6	6
Anemia	6	6
Calcium Deposits/Calcification	6	6
Necrosis	6	6
Skin Inflammation/ Irritation	6	6
Unspecified Kidney or Urinary Problem	5	5
Pocket Erosion	5	5
Headache	5	5
Low Blood Pressure/ Hypotension	5	5
Failure of Implant	5	5
Laceration(s)	5	5
Muscle Weakness	5	5
Arthritis	5	5
Dehydration	5	5
Foreign Body Reaction	5	5
Foreign Body In Patient	5	5
Blurred Vision	5	5
Tissue Damage	5	5
Chills	5	5
Cramp(s)	4	4
Dizziness	4	4
Weakness	4	4
Sore Throat	4	4
Osteopenia/ Osteoporosis	4	4
Ascites	4	4
Cellulitis	4	4
Chest Pain	4	4
Irritation	4	4
Sepsis	4	4
Neuropathy	4	4
Internal Organ Perforation	3	3