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
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
Back to Search Results
Device
mesh, surgical, polymeric
Regulation Description
Surgical mesh.
Product Code
FTL
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
8
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
4
ETHICON
SUBSTANTIALLY EQUIVALENT
7
ETHICON INC.
SUBSTANTIALLY EQUIVALENT
1
ETHICON, INC
SUBSTANTIALLY EQUIVALENT
1
ETHICON, INC.
SUBSTANTIALLY EQUIVALENT
5
INTERNATIONAL LIFE SCIENCES
SUBSTANTIALLY EQUIVALENT
1
MAST BIOSURGERY USA INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
4
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
4
PROXY BIOMEDICAL LTD
SUBSTANTIALLY EQUIVALENT
1
PROXY BIOMEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
W.L. GORE & ASSOCIATES,INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
2391
2391
2017
3927
3927
2018
11866
11866
2019
21720
21720
2020
18814
18814
2021
1026
1026
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
31849
31849
Defective Device
29733
29733
Adverse Event Without Identified Device or Use Problem
21007
21007
Appropriate Term/Code Not Available
3189
3189
Migration or Expulsion of Device
2811
2811
Patient Device Interaction Problem
974
974
Patient-Device Incompatibility
782
782
Material Deformation
558
558
Material Erosion
516
516
Loss of or Failure to Bond
509
509
Material Split, Cut or Torn
441
441
Material Integrity Problem
369
369
Detachment of Device or Device Component
266
266
Degraded
154
154
Material Perforation
149
149
Break
145
145
No Apparent Adverse Event
138
138
Migration
136
136
Material Separation
120
120
Device Operates Differently Than Expected
119
119
Torn Material
91
91
Use of Device Problem
78
78
Material Protrusion/Extrusion
72
72
Therapeutic or Diagnostic Output Failure
67
67
Product Quality Problem
67
67
Contamination
60
60
Microbial Contamination of Device
57
57
Extrusion
54
54
Hole In Material
48
48
Failure To Adhere Or Bond
44
44
Tear, Rip or Hole in Device Packaging
44
44
Mechanics Altered
40
40
Detachment Of Device Component
37
37
Folded
36
36
Packaging Problem
32
32
Improper or Incorrect Procedure or Method
29
29
Device Markings/Labelling Problem
28
28
Material Frayed
26
26
Expiration Date Error
26
26
Unsealed Device Packaging
25
25
Material Disintegration
25
25
Material Twisted/Bent
25
25
Deformation Due to Compressive Stress
23
23
Entrapment of Device
22
22
Unexpected Therapeutic Results
21
21
Device Dislodged or Dislocated
21
21
Nonstandard Device
18
18
Defective Component
18
18
Device Contamination with Chemical or Other Material
18
18
Peeled/Delaminated
14
14
Shelf Life Exceeded
14
14
Structural Problem
14
14
Device Expiration Issue
13
13
Loosening of Implant Not Related to Bone-Ingrowth
12
12
Material Rupture
12
12
Physical Resistance/Sticking
12
12
Loose or Intermittent Connection
11
11
Sticking
10
10
Material Puncture/Hole
10
10
Difficult to Remove
10
10
Material Fragmentation
10
10
Human-Device Interface Problem
10
10
Delamination
10
10
Failure to Osseointegrate
9
9
Material Too Rigid or Stiff
8
8
Device Damaged by Another Device
8
8
Incorrect, Inadequate or Imprecise Resultor Readings
8
8
Delivered as Unsterile Product
8
8
Device Appears to Trigger Rejection
8
8
Unintended Movement
7
7
Contamination /Decontamination Problem
7
7
Device Slipped
7
7
Device Issue
6
6
Obstruction of Flow
6
6
Retraction Problem
6
6
Malposition of Device
6
6
Positioning Problem
6
6
Component Missing
5
5
Difficult to Open or Close
5
5
Expulsion
4
4
Off-Label Use
4
4
Ring
4
4
Protective Measures Problem
4
4
Inadequacy of Device Shape and/or Size
4
4
Unraveled Material
3
3
Kinked
3
3
Difficult or Delayed Positioning
3
3
Device-Device Incompatibility
3
3
Biocompatibility
3
3
Bent
3
3
Crack
3
3
Mechanical Problem
3
3
Inflation Problem
3
3
Device Emits Odor
3
3
Difficult To Position
2
2
Fracture
2
2
Explanted
2
2
Device Packaging Compromised
2
2
Device Or Device Fragments Location Unknown
2
2
Wrinkled
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
41687
41687
Pain
29645
29649
Disability
17566
17566
Hernia
13786
13790
Adhesion(s)
11673
11678
No Code Available
7309
7311
Unspecified Infection
7174
7178
Inflammation
3540
3543
Not Applicable
3015
3015
Abdominal Pain
2905
2908
Obstruction/Occlusion
2461
2461
Abscess
2369
2371
Scarring
1793
1795
Seroma
1765
1768
Erosion
1650
1652
Nausea
1616
1617
Discomfort
1396
1397
Fistula
1367
1369
Impaired Healing
1193
1196
Purulent Discharge
1151
1151
Scar Tissue
1132
1132
Failure of Implant
969
970
No Information
915
916
Discharge
912
912
Unspecified Tissue Injury
855
855
Abdominal Distention
848
848
Foreign Body Reaction
768
770
Hematoma
756
756
Swelling
709
709
Necrosis
698
698
No Consequences Or Impact To Patient
649
649
Blood Loss
636
636
Nerve Damage
623
625
Emotional Changes
586
587
Ascites
534
534
Fibrosis
533
533
Vomiting
530
531
Incontinence
522
522
Prolapse
402
402
Fever
369
369
Diarrhea
356
356
Deformity/ Disfigurement
354
354
Bacterial Infection
299
299
Wound Dehiscence
297
297
Fluid Discharge
286
286
Urinary Tract Infection
278
278
Cellulitis
267
267
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
256
256
Granuloma
252
253
Chills
248
248
Erythema
236
236
Bowel Perforation
229
229
Weight Changes
223
223
Sepsis
222
223
Urinary Retention
209
209
Constipation
209
209
Hemorrhage/Bleeding
208
208
Staphylococcus Aureus
200
200
Death
197
197
Post Operative Wound Infection
197
198
Edema
192
193
No Known Impact Or Consequence To Patient
186
186
Reaction
183
184
Perforation
182
182
Urinary Frequency
170
170
Internal Organ Perforation
164
164
Foreign Body In Patient
164
164
Burning Sensation
160
160
Tissue Damage
158
160
Ischemia
149
149
Distress
118
118
Cyst(s)
117
117
Micturition Urgency
113
113
Hematuria
109
109
Rash
106
106
Complaint, Ill-Defined
98
98
Weakness
98
98
Depression
97
97
Abnormal Vaginal Discharge
86
86
Ambulation Difficulties
86
86
Dysuria
85
85
Fatigue
82
82
Itching Sensation
76
76
Cramp(s)
73
73
Anxiety
72
72
Peritonitis
70
70
Numbness
70
70
Strangulation
68
68
Ulcer
63
63
Patient Problem/Medical Problem
63
63
Neuropathy
60
60
Corneal Pannus
59
59
Low Blood Pressure/ Hypotension
59
60
Ulceration
59
59
Tachycardia
59
59
Anemia
58
59
Hypersensitivity/Allergic reaction
57
58
Therapeutic Response, Decreased
55
55
Excessive Tear Production
52
52
Hypoesthesia
47
47
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Feb-23-2018
2
Covidien LLC
II
Nov-14-2018
3
Covidien LLC
II
Jul-12-2018
4
Covidien Llc
II
Feb-22-2021
5
Ethicon, Inc.
II
Dec-03-2020
6
Novus Scientific Ab
II
Aug-19-2016
7
Sofradim Production
II
Apr-26-2018
8
TYRX Inc.
II
Aug-15-2016
-
-