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TPLC
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Device
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Definition
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
Product Code
OTN
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
ATHENA SURGICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
2
CALDERA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ETHICON INC.
SUBSTANTIALLY EQUIVALENT
1
UROCURE LLC
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2019
2455
2455
2020
1003
1003
2021
2605
2605
2022
809
809
2023
1076
1076
2024
655
655
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
6089
6089
Migration
1578
1578
Appropriate Term/Code Not Available
484
484
Insufficient Information
181
181
Positioning Problem
81
81
Material Integrity Problem
55
55
Material Erosion
54
54
Detachment of Device or Device Component
41
41
Material Protrusion/Extrusion
33
33
Material Twisted/Bent
30
30
Patient-Device Incompatibility
29
29
Material Split, Cut or Torn
25
25
Patient Device Interaction Problem
21
21
Defective Device
20
20
Device Appears to Trigger Rejection
18
18
Migration or Expulsion of Device
15
15
Break
13
13
Difficult to Advance
13
13
Material Deformation
12
12
Use of Device Problem
10
10
Fracture
9
9
Material Separation
9
9
Therapeutic or Diagnostic Output Failure
7
7
Difficult to Remove
7
7
No Apparent Adverse Event
6
6
Device Dislodged or Dislocated
5
5
Difficult or Delayed Positioning
5
5
Unsealed Device Packaging
5
5
Degraded
4
4
Unraveled Material
4
4
Material Disintegration
4
4
Material Fragmentation
3
3
Improper or Incorrect Procedure or Method
3
3
Device Contaminated During Manufacture or Shipping
3
3
Output Problem
3
3
Contamination
3
3
Device Contamination with Chemical or Other Material
2
2
Inadequacy of Device Shape and/or Size
2
2
Defective Component
2
2
Device Damaged Prior to Use
2
2
Delivered as Unsterile Product
2
2
Packaging Problem
2
2
Material Perforation
1
1
Device Damaged by Another Device
1
1
Material Too Rigid or Stiff
1
1
Obstruction of Flow
1
1
Missing Information
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Unclear Information
1
1
Peeled/Delaminated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
3790
3790
Erosion
2389
2389
Insufficient Information
1550
1550
Injury
1509
1509
Incontinence
1504
1504
Not Applicable
1035
1035
Urinary Tract Infection
910
910
Dyspareunia
861
861
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
594
594
Constipation
593
593
Urinary Retention
567
567
Micturition Urgency
545
545
Unspecified Infection
465
465
Urinary Incontinence
429
429
No Code Available
413
413
Urinary Frequency
401
401
Hemorrhage/Bleeding
398
398
Abnormal Vaginal Discharge
398
398
Inflammation
346
346
Prolapse
337
337
Scar Tissue
297
297
Discomfort
296
296
Unspecified Mental, Emotional or Behavioural Problem
276
276
Abdominal Pain
271
271
Dysuria
244
244
Obstruction/Occlusion
221
221
Nerve Damage
161
161
Hematuria
158
158
Adhesion(s)
154
154
Fatigue
147
147
Depression
146
146
Unspecified Kidney or Urinary Problem
138
138
Anxiety
130
130
Unspecified Tissue Injury
125
125
Burning Sensation
124
124
Cramp(s) /Muscle Spasm(s)
123
123
No Clinical Signs, Symptoms or Conditions
117
117
Blood Loss
101
101
Numbness
97
97
Bacterial Infection
94
94
Ambulation Difficulties
91
91
Abscess
89
89
Hematoma
88
88
Nausea
87
87
Fistula
85
85
Perforation
84
84
Disability
74
74
Fever
70
70
Swelling/ Edema
68
68
Deformity/ Disfigurement
66
66
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