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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
527
527
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
7728
7728
Appropriate Term/Code Not Available
2520
2520
Migration or Expulsion of Device
1978
1978
Migration
1631
1631
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
43
43
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
Material Frayed
9
9
Hole In Material
8
8
Unsealed Device Packaging
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
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
Contamination
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
7306
7307
Erosion
5777
5777
No Code Available
4011
4011
Incontinence
2790
2790
Injury
2296
2296
Insufficient Information
1562
1562
Not Applicable
1455
1455
Urinary Tract Infection
1389
1389
Unspecified Infection
1199
1199
Other (for use when an appropriate patient code cannot be identified)
1005
1005
Surgical procedure
980
980
Urinary Retention
920
920
Dyspareunia
852
852
Micturition Urgency
788
788
Urinary Frequency
655
656
Constipation
630
630
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
586
586
Inflammation
498
498
Prolapse
475
475
Abnormal Vaginal Discharge
474
474
No Information
467
467
Scar Tissue
449
449
Hemorrhage/Bleeding
440
441
Urinary Incontinence
422
422
Discomfort
410
410
Blood Loss
366
366
Death
363
363
Dysuria
336
336
Abdominal Pain
329
329
Obstruction/Occlusion
295
295
Hematuria
279
279
Unspecified Mental, Emotional or Behavioural Problem
275
275
Nerve Damage
231
231
Adhesion(s)
229
229
No Consequences Or Impact To Patient
219
219
Emotional Changes
189
189
Burning Sensation
185
185
Fatigue
184
184
Scarring
172
172
Depression
167
167
Fistula
160
160
Ambulation Difficulties
159
159
Anxiety
148
148
Perforation
140
140
Internal Organ Perforation
133
133
Unspecified Kidney or Urinary Problem
131
131
Unspecified Tissue Injury
126
126
Hematoma
126
126
Disability
126
126
Cramp(s) /Muscle Spasm(s)
120
120
Bleeding
117
117
Numbness
112
112
Abscess
109
109
Neurological Deficit/Dysfunction
105
105
Bacterial Infection
103
103
No Clinical Signs, Symptoms or Conditions
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
68
68
Sleep Dysfunction
68
68
No Known Impact Or Consequence To Patient
67
67
Vomiting
66
66
Cyst(s)
65
65
Swelling/ Edema
65
65
Foreign Body Reaction
63
63
Headache
62
62
Sepsis
62
62
Hernia
61
61
Discharge
60
60
Intermenstrual Bleeding
58
58
Muscle Weakness
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
Stenosis
32
32
Skin Inflammation/ Irritation
32
32
Therapeutic Response, Decreased
31
31
Chills
31
31
Purulent Discharge
31
31
Pocket Erosion
31
31
Recalls
Manufacturer
Recall Class
Date Posted
1
American Medical Systems, Inc.
II
Dec-16-2014
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