Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
AMERICAN MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
AMERICAN MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
ATHENA SURGICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORP.
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
2
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
CALDERA MEDICAL
SUBSTANTIALLY EQUIVALENT
1
CALDERA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
6
COLOPLAST A/S
SUBSTANTIALLY EQUIVALENT
1
ETHICON INC.
SUBSTANTIALLY EQUIVALENT
1
ETHICON, INC.
SUBSTANTIALLY EQUIVALENT
3
GENERIC MEDICAL DEVICE, INC.
SUBSTANTIALLY EQUIVALENT
2
GENERIC MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
MPATHY MEDICAL DEVICES, LTD.
SUBSTANTIALLY EQUIVALENT
1
NEOMEDIC INTERNATIONAL S.L.
SUBSTANTIALLY EQUIVALENT
1
UROCURE LLC
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2014
2050
2050
2015
3900
3900
2016
1900
1900
2017
675
675
2018
737
737
2019
2455
2455
2020
1003
1003
2021
2605
2605
2022
809
809
2023
1076
1076
2024
555
555
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
7744
7744
Appropriate Term/Code Not Available
2521
2521
Migration or Expulsion of Device
1978
1978
Migration
1636
1636
Insufficient Information
1570
1570
Material Erosion
1104
1104
Other (for use when an appropriate device code cannot be identified)
777
777
Extrusion
152
152
Break
94
94
Positioning Problem
83
83
Device Operates Differently Than Expected
72
72
Patient-Device Incompatibility
69
69
Material Integrity Problem
55
55
Material Protrusion/Extrusion
50
50
Detachment of Device or Device Component
47
47
Material Twisted/Bent
41
41
Difficult to Advance
29
29
Material Split, Cut or Torn
29
29
Detachment Of Device Component
29
29
Material Deformation
25
25
Defective Device
24
24
No Apparent Adverse Event
22
22
Torn Material
22
22
Patient Device Interaction Problem
22
22
Device Appears to Trigger Rejection
19
19
Difficult to Remove
16
16
Malposition of Device
16
16
Material Separation
15
15
Use of Device Problem
11
11
Improper or Incorrect Procedure or Method
11
11
Therapeutic or Diagnostic Output Failure
11
11
Device Dislodged or Dislocated
10
10
Unsealed Device Packaging
9
9
Material Frayed
9
9
Hole In Material
8
8
Fracture
8
8
Material Fragmentation
8
8
Degraded
7
7
Material Perforation
7
7
Separation Failure
7
7
Tear, Rip or Hole in Device Packaging
6
6
Sticking
6
6
Difficult or Delayed Positioning
6
6
Bent
6
6
Device Packaging Compromised
5
5
Folded
4
4
Contamination
4
4
Material Disintegration
4
4
Unraveled Material
4
4
Unknown (for use when the device problem is not known)
4
4
Implant extrusion
4
4
Defective Component
4
4
Material Rupture
4
4
Device Or Device Fragments Location Unknown
3
3
Loose or Intermittent Connection
3
3
Material Puncture/Hole
3
3
Device Contamination with Chemical or Other Material
3
3
Device Contaminated During Manufacture or Shipping
3
3
Output Problem
3
3
Packaging Problem
2
2
Activation, Positioning or Separation Problem
2
2
Scratched Material
2
2
Device Markings/Labelling Problem
2
2
Difficult to Insert
2
2
Delivered as Unsterile Product
2
2
Entrapment of Device
2
2
Explanted
2
2
Fluid/Blood Leak
2
2
Reaction
2
2
Inadequacy of Device Shape and/or Size
2
2
Stretched
2
2
Device Damaged Prior to Use
2
2
Obstruction of Flow
2
2
Cut In Material
1
1
Split
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Device Issue
1
1
Device Displays Incorrect Message
1
1
Biocompatibility
1
1
Connection Problem
1
1
Delamination
1
1
Fitting Problem
1
1
Device Inoperable
1
1
Unstable
1
1
Device Slipped
1
1
Failure To Adhere Or Bond
1
1
Flaked
1
1
Crack
1
1
Disconnection
1
1
Loss of or Failure to Bond
1
1
Calcified
1
1
Device Emits Odor
1
1
Overheating of Device
1
1
Kinked
1
1
Leak/Splash
1
1
Product Quality Problem
1
1
Peeled/Delaminated
1
1
Difficult To Position
1
1
Retraction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
7320
7321
Erosion
5784
5784
No Code Available
4011
4011
Incontinence
2793
2793
Injury
2296
2296
Insufficient Information
1563
1563
Not Applicable
1455
1455
Urinary Tract Infection
1397
1397
Unspecified Infection
1201
1201
Other (for use when an appropriate patient code cannot be identified)
1005
1005
Surgical procedure
980
980
Urinary Retention
923
923
Dyspareunia
854
854
Micturition Urgency
793
793
Urinary Frequency
658
659
Constipation
631
631
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
587
587
Inflammation
500
500
Prolapse
477
477
Abnormal Vaginal Discharge
476
476
No Information
467
467
Scar Tissue
449
449
Hemorrhage/Bleeding
441
442
Urinary Incontinence
425
425
Discomfort
411
411
Blood Loss
366
366
Death
363
363
Dysuria
337
337
Abdominal Pain
331
331
Obstruction/Occlusion
296
296
Hematuria
280
280
Unspecified Mental, Emotional or Behavioural Problem
275
275
Nerve Damage
231
231
Adhesion(s)
230
230
No Consequences Or Impact To Patient
219
219
Emotional Changes
189
189
Fatigue
186
186
Burning Sensation
186
186
Scarring
172
172
Depression
167
167
Fistula
161
161
Ambulation Difficulties
160
160
Anxiety
148
148
Perforation
141
141
Unspecified Kidney or Urinary Problem
134
134
Internal Organ Perforation
133
133
Unspecified Tissue Injury
128
128
Hematoma
126
126
Disability
126
126
Cramp(s) /Muscle Spasm(s)
122
122
Bleeding
117
117
Numbness
112
112
Abscess
110
110
No Clinical Signs, Symptoms or Conditions
108
108
Neurological Deficit/Dysfunction
105
105
Bacterial Infection
103
103
Nausea
102
102
Fever
94
94
Itching Sensation
78
78
Calcium Deposits/Calcification
77
77
Deformity/ Disfigurement
76
76
Treatment with medication(s)
73
73
Diarrhea
69
69
Hypersensitivity/Allergic reaction
69
69
Sleep Dysfunction
68
68
No Known Impact Or Consequence To Patient
67
67
Swelling/ Edema
66
66
Vomiting
66
66
Cyst(s)
66
66
Foreign Body Reaction
63
63
Headache
62
62
Sepsis
62
62
Hernia
62
62
Discharge
60
60
Muscle Weakness
59
59
Intermenstrual Bleeding
58
58
Swelling
56
56
Fibrosis
51
51
Rash
50
50
High Blood Pressure/ Hypertension
50
50
Wound Dehiscence
46
46
Abdominal Distention
45
45
Foreign Body In Patient
45
46
Weight Changes
43
43
Fecal Incontinence
42
42
Complaint, Ill-Defined
41
41
Tissue Damage
40
40
Skin Erosion
39
39
Genital Bleeding
39
39
Neuropathy
38
38
Sexual Dysfunction
37
37
Muscle Spasm(s)
36
36
Fungal Infection
35
35
Autoimmune Disorder
33
33
Purulent Discharge
32
32
Stenosis
32
32
Skin Inflammation/ Irritation
32
32
Therapeutic Response, Decreased
31
31
Chills
31
31
Pocket Erosion
31
31
Recalls
Manufacturer
Recall Class
Date Posted
1
American Medical Systems, Inc.
II
Dec-16-2014
-
-