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TPLC
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Device
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Regulation Description
Surgical mesh.
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
2
MDR Year
MDR Reports
MDR Events
2020
1004
1004
2021
2606
2606
2022
809
809
2023
1076
1076
2024
821
821
2025
32
32
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4267
4267
Migration
1204
1204
Appropriate Term/Code Not Available
493
493
Insufficient Information
101
101
Positioning Problem
79
79
Material Integrity Problem
53
53
Material Erosion
44
44
Detachment of Device or Device Component
39
39
Material Twisted/Bent
28
28
Material Protrusion/Extrusion
27
27
Patient Device Interaction Problem
22
22
Material Split, Cut or Torn
21
21
Device Appears to Trigger Rejection
18
18
Defective Device
17
17
Migration or Expulsion of Device
13
13
Break
13
13
Patient-Device Incompatibility
10
10
Difficult to Advance
10
10
Material Deformation
9
9
Use of Device Problem
9
9
Fracture
9
9
Material Separation
7
7
Difficult to Remove
6
6
Difficult or Delayed Positioning
5
5
Device Dislodged or Dislocated
5
5
Therapeutic or Diagnostic Output Failure
5
5
Unsealed Device Packaging
4
4
Unraveled Material
4
4
Material Disintegration
4
4
No Apparent Adverse Event
4
4
Degraded
4
4
Improper or Incorrect Procedure or Method
3
3
Output Problem
3
3
Contamination
3
3
Device Contaminated During Manufacture or Shipping
3
3
Device Damaged Prior to Use
2
2
Material Fragmentation
2
2
Malposition of Device
2
2
Inadequacy of Device Shape and/or Size
2
2
Delivered as Unsterile Product
2
2
Device Contamination with Chemical or Other Material
2
2
Defective Component
2
2
Missing Information
2
2
Crack
1
1
Unclear Information
1
1
Electromagnetic Compatibility Problem
1
1
Device-Device Incompatibility
1
1
Fluid/Blood Leak
1
1
Calcified
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
3190
3190
Erosion
1953
1953
Insufficient Information
1550
1550
Incontinence
1260
1260
Dyspareunia
878
878
Urinary Tract Infection
751
751
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
597
597
Constipation
576
576
Micturition Urgency
498
498
Urinary Retention
483
483
Urinary Incontinence
454
454
Unspecified Infection
407
407
Abnormal Vaginal Discharge
394
394
Hemorrhage/Bleeding
391
391
Urinary Frequency
361
361
Injury
325
325
Inflammation
319
319
Prolapse
311
311
No Code Available
291
291
Scar Tissue
288
288
Unspecified Mental, Emotional or Behavioural Problem
288
288
Discomfort
266
266
Abdominal Pain
247
247
Not Applicable
238
238
Dysuria
226
226
Obstruction/Occlusion
185
185
Unspecified Kidney or Urinary Problem
148
148
Nerve Damage
145
145
Hematuria
138
138
Depression
134
134
Unspecified Tissue Injury
131
131
No Clinical Signs, Symptoms or Conditions
131
131
Adhesion(s)
130
130
Cramp(s) /Muscle Spasm(s)
126
126
Anxiety
120
120
Burning Sensation
115
115
Fatigue
113
113
Numbness
91
91
Ambulation Difficulties
90
90
Bacterial Infection
89
89
Nausea
83
83
Fistula
78
78
Abscess
73
73
Perforation
73
73
Hematoma
72
72
Swelling/ Edema
68
68
Muscle Weakness
65
65
Deformity/ Disfigurement
65
65
Fever
62
62
Diarrhea
57
57
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