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TPLC
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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
Premarket Reviews
Manufacturer
Decision
CALDERA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
COLOPLAST A/S
SUBSTANTIALLY EQUIVALENT
1
COLOPLAST CORP
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
170
170
2021
318
318
2022
159
159
2023
154
154
2024
287
287
2025
89
89
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
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