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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
AMERICAN MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
AMERICAN MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
2
CALDERA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
COLOPLAST A/S
SUBSTANTIALLY EQUIVALENT
2
MPATHY MEDICAL DEVICES, LTD.
SUBSTANTIALLY EQUIVALENT
1
PROMEDON S.A.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
334
334
2015
274
274
2016
697
697
2017
127
127
2018
173
173
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
1072
1072
Insufficient Information
624
624
Break
184
184
Material Erosion
182
182
Migration
160
160
Appropriate Term/Code Not Available
130
130
Migration or Expulsion of Device
88
88
Extrusion
68
68
Material Protrusion/Extrusion
52
52
Device Operates Differently Than Expected
48
48
Detachment of Device or Device Component
47
47
Positioning Failure
42
42
Device Dislodged or Dislocated
38
38
Patient-Device Incompatibility
38
38
Material Twisted/Bent
30
30
Positioning Problem
28
28
Device Appears to Trigger Rejection
27
27
Other (for use when an appropriate device code cannot be identified)
24
24
No Apparent Adverse Event
19
19
Detachment Of Device Component
18
18
Material Deformation
18
18
Malposition of Device
16
16
Bent
13
13
Material Split, Cut or Torn
12
12
Defective Device
12
12
Difficult to Advance
11
11
Material Fragmentation
11
11
Premature Activation
10
10
Fracture
9
9
Patient Device Interaction Problem
7
7
Loose or Intermittent Connection
7
7
Torn Material
6
6
Missing Information
6
6
Therapeutic or Diagnostic Output Failure
6
6
Material Separation
6
6
Improper or Incorrect Procedure or Method
5
5
Unexpected Therapeutic Results
5
5
Unintended Movement
4
4
Material Frayed
4
4
Difficult To Position
4
4
Device Slipped
4
4
Deformation Due to Compressive Stress
3
3
Device Or Device Fragments Location Unknown
3
3
Difficult or Delayed Separation
3
3
Difficult to Remove
3
3
Leak/Splash
3
3
Inadequacy of Device Shape and/or Size
2
2
Stretched
2
2
Entrapment of Device
2
2
Obstruction of Flow
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
1245
1245
Erosion
716
716
Incontinence
578
578
Injury
427
427
Urinary Tract Infection
296
296
Urinary Retention
285
285
Unspecified Infection
276
276
No Code Available
226
226
No Clinical Signs, Symptoms or Conditions
209
209
Micturition Urgency
209
209
Dysuria
160
160
Dyspareunia
159
159
Urinary Frequency
151
151
Urinary Incontinence
150
150
Hemorrhage/Bleeding
132
132
No Information
127
127
Prolapse
126
126
Surgical procedure
103
103
Insufficient Information
101
101
Death
99
99
Discomfort
97
97
Abnormal Vaginal Discharge
96
96
Scar Tissue
96
96
Inflammation
91
91
Scarring
86
86
Abdominal Pain
85
85
No Consequences Or Impact To Patient
84
84
Emotional Changes
81
81
No Known Impact Or Consequence To Patient
80
80
Hematuria
78
78
Not Applicable
77
77
Blood Loss
66
66
Constipation
63
63
Other (for use when an appropriate patient code cannot be identified)
61
61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
56
56
Burning Sensation
48
48
Complaint, Ill-Defined
47
47
Foreign Body Reaction
47
47
Obstruction/Occlusion
41
41
Internal Organ Perforation
40
40
Perforation
39
39
Intermenstrual Bleeding
37
37
Bacterial Infection
34
34
Fistula
33
33
Tissue Damage
33
33
Nerve Damage
31
31
Foreign Body In Patient
31
31
Cramp(s) /Muscle Spasm(s)
30
30
Laceration(s)
29
29
Nausea
28
28
Recalls
Manufacturer
Recall Class
Date Posted
1
Astora
II
Nov-16-2015
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