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TPLC
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Device
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
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
MDR Year
MDR Reports
MDR Events
2019
297
297
2020
171
171
2021
318
318
2022
159
159
2023
154
154
2024
186
186
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
612
612
Migration
150
150
Break
118
118
Insufficient Information
87
87
Appropriate Term/Code Not Available
82
82
Detachment of Device or Device Component
46
46
Device Dislodged or Dislocated
29
29
Material Protrusion/Extrusion
28
28
Material Twisted/Bent
25
25
Device Appears to Trigger Rejection
25
25
No Apparent Adverse Event
19
19
Positioning Failure
17
17
Positioning Problem
17
17
Material Deformation
16
16
Material Erosion
15
15
Material Split, Cut or Torn
12
12
Difficult to Advance
11
11
Migration or Expulsion of Device
11
11
Material Fragmentation
10
10
Defective Device
10
10
Fracture
8
8
Patient-Device Incompatibility
7
7
Premature Activation
7
7
Patient Device Interaction Problem
7
7
Missing Information
6
6
Material Frayed
4
4
Material Separation
4
4
Difficult or Delayed Separation
3
3
Malposition of Device
3
3
Loose or Intermittent Connection
3
3
Difficult to Remove
2
2
Improper or Incorrect Procedure or Method
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Slipped
2
2
Separation Problem
2
2
Deformation Due to Compressive Stress
1
1
Activation Failure
1
1
Mechanical Problem
1
1
Deflation Problem
1
1
Unsealed Device Packaging
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Defective Component
1
1
Human-Device Interface Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Contaminated During Manufacture or Shipping
1
1
Degraded
1
1
Activation, Positioning or Separation Problem
1
1
Disconnection
1
1
Material Too Rigid or Stiff
1
1
Difficult or Delayed Positioning
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
494
494
Erosion
361
361
No Clinical Signs, Symptoms or Conditions
209
209
Incontinence
190
190
Injury
168
168
Dyspareunia
158
158
Urinary Incontinence
148
148
Urinary Tract Infection
143
143
Urinary Retention
117
117
Micturition Urgency
115
115
Insufficient Information
101
101
Unspecified Infection
78
78
Dysuria
77
77
Urinary Frequency
72
72
No Code Available
69
69
Abnormal Vaginal Discharge
68
68
Scar Tissue
66
66
Prolapse
65
65
Inflammation
59
59
Not Applicable
57
57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
55
55
Constipation
50
50
Discomfort
49
49
Hematuria
47
47
Abdominal Pain
38
38
No Consequences Or Impact To Patient
36
36
Hemorrhage/Bleeding
34
34
Foreign Body Reaction
34
34
Intermenstrual Bleeding
33
33
Cramp(s) /Muscle Spasm(s)
30
30
Bacterial Infection
29
29
Burning Sensation
29
29
Genital Bleeding
27
27
No Information
24
24
Unspecified Kidney or Urinary Problem
21
21
Depression
21
21
Obstruction/Occlusion
21
21
Nerve Damage
19
19
Perforation
19
19
Muscle Weakness
19
19
Foreign Body In Patient
18
18
Nausea
17
17
Anxiety
17
17
Unspecified Mental, Emotional or Behavioural Problem
16
16
Skin Erosion
16
16
Deformity/ Disfigurement
16
16
Adhesion(s)
16
16
Kidney Infection
14
14
Fistula
14
14
Sexual Dysfunction
14
14
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