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TPLC
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Device
mesh, surgical, polymeric
Product Code
FTL
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARISTE MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
AROA BIOSURGERY LTD.
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
CR BARD INC.
SUBSTANTIALLY EQUIVALENT
1
DEEP BLUE MEDICAL ADVANCES, INC.
SUBSTANTIALLY EQUIVALENT
2
ETHICON INC
SUBSTANTIALLY EQUIVALENT
1
ETHICON, INC
SUBSTANTIALLY EQUIVALENT
1
ETHICON, INC.
SUBSTANTIALLY EQUIVALENT
3
EXOGENESIS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
FEG TEXTILTECHNIK FORSCHUNGS- UND ENTWICKLUNGSGESELLSCHAFT
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL LIFE SCIENCES
SUBSTANTIALLY EQUIVALENT
1
MAST BIOSURGERY
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
4
PROXY BIOMEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
SOFRADIM PRODUCTION
SUBSTANTIALLY EQUIVALENT
5
SURGICAL INNOVATION ASSOCIATES, INC.
SUBSTANTIALLY EQUIVALENT
1
XIROS LTD
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
11877
11877
2019
21721
21721
2020
18816
18816
2021
16286
16286
2022
11438
11438
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Device
45080
45080
Insufficient Information
31528
31528
Adverse Event Without Identified Device or Use Problem
27127
27127
Patient Device Interaction Problem
17893
17893
Migration or Expulsion of Device
3930
3930
Mechanics Altered
3159
3159
Appropriate Term/Code Not Available
1962
1962
Patient-Device Incompatibility
1480
1480
Material Deformation
887
887
Material Split, Cut or Torn
696
696
Material Integrity Problem
539
539
Loss of or Failure to Bond
495
495
Material Erosion
416
416
Migration
361
361
Degraded
308
308
Detachment of Device or Device Component
268
268
Material Perforation
134
134
No Apparent Adverse Event
124
124
Material Separation
90
90
Therapeutic or Diagnostic Output Failure
89
89
Material Protrusion/Extrusion
86
86
Break
83
83
Product Quality Problem
72
72
Use of Device Problem
60
60
Microbial Contamination of Device
55
55
Expiration Date Error
50
50
Contamination
48
48
Device Operates Differently Than Expected
45
45
Device Markings/Labelling Problem
40
40
Improper or Incorrect Procedure or Method
37
37
Delivered as Unsterile Product
35
35
Material Twisted/Bent
35
35
Packaging Problem
31
31
Device Contamination with Chemical or Other Material
29
29
Tear, Rip or Hole in Device Packaging
27
27
Torn Material
24
24
Material Disintegration
23
23
Device Dislodged or Dislocated
22
22
Output Problem
21
21
Entrapment of Device
21
21
Material Frayed
19
19
Structural Problem
19
19
Unexpected Therapeutic Results
19
19
Defective Component
18
18
Device Appears to Trigger Rejection
15
15
Physical Resistance/Sticking
14
14
Loosening of Implant Not Related to Bone-Ingrowth
13
13
Unsealed Device Packaging
13
13
Peeled/Delaminated
13
13
Material Fragmentation
11
11
Detachment Of Device Component
11
11
Material Puncture/Hole
11
11
Failure to Osseointegrate
11
11
Deformation Due to Compressive Stress
11
11
Failure To Adhere Or Bond
10
10
Off-Label Use
10
10
Folded
9
9
Extrusion
9
9
Human-Device Interface Problem
8
8
Contamination /Decontamination Problem
8
8
Unintended Movement
8
8
Loose or Intermittent Connection
8
8
Device Expiration Issue
8
8
Nonstandard Device
7
7
Shelf Life Exceeded
7
7
Malposition of Device
7
7
Expulsion
6
6
Retraction Problem
6
6
Difficult to Remove
6
6
Device Slipped
6
6
Component Missing
6
6
Obstruction of Flow
6
6
Sticking
5
5
Device Damaged by Another Device
5
5
Difficult to Open or Close
4
4
Device Contaminated During Manufacture or Shipping
4
4
Positioning Problem
4
4
Protective Measures Problem
4
4
Inadequacy of Device Shape and/or Size
4
4
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Material Too Rigid or Stiff
4
4
Material Rupture
3
3
Unraveled Material
3
3
Mechanical Problem
3
3
Fracture
3
3
Hole In Material
3
3
Inflation Problem
3
3
Crack
3
3
Device-Device Incompatibility
3
3
Compatibility Problem
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Biocompatibility
2
2
Component Misassembled
2
2
Device Fell
2
2
Lack of Effect
2
2
Difficult or Delayed Positioning
2
2
Disconnection
2
2
Inadequate Instructions for Healthcare Professional
2
2
Material Invagination
2
2
Leak/Splash
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
41973
41982
Injury
40945
40945
Hernia
18007
18011
Disability
17374
17374
Adhesion(s)
15995
16004
Insufficient Information
15850
15850
Unspecified Infection
8698
8705
Unspecified Tissue Injury
8539
8539
Inflammation
7176
7179
No Code Available
4866
4868
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3758
3758
Scar Tissue
3630
3630
Obstruction/Occlusion
3623
3623
Abdominal Pain
3548
3551
Emotional Changes
3521
3522
Abscess
3274
3276
Discomfort
2837
2838
Not Applicable
2763
2763
Nausea
2757
2758
Seroma
2447
2450
Erosion
1897
1899
Fistula
1796
1801
Scarring
1587
1589
Impaired Healing
1443
1446
Failure of Implant
1379
1380
Purulent Discharge
1300
1300
Diarrhea
1193
1193
Foreign Body Reaction
1192
1194
Abdominal Distention
1126
1126
Fluid Discharge
1122
1122
No Clinical Signs, Symptoms or Conditions
1048
1048
Chills
1037
1037
Hematoma
958
958
Decreased Appetite
956
956
Nerve Damage
935
937
Necrosis
929
929
Weight Changes
881
881
Discharge
799
799
Ascites
744
744
Fibrosis
713
713
Swelling/ Edema
712
712
Vomiting
632
633
Swelling
571
571
No Information
562
562
Deformity/ Disfigurement
559
559
Hemorrhage/Bleeding
555
555
Bacterial Infection
520
520
Blood Loss
472
472
Distress
459
459
Fever
427
427
Perforation
392
392
No Consequences Or Impact To Patient
387
387
Wound Dehiscence
386
386
Constipation
324
324
Cellulitis
323
323
Incontinence
311
311
Erythema
309
309
Granuloma
301
302
Urinary Tract Infection
258
258
Sepsis
252
253
Muscle Weakness
250
250
Nodule
230
230
Bowel Perforation
229
229
Prolapse
226
226
Urinary Retention
223
223
Post Operative Wound Infection
220
221
Burning Sensation
184
184
Death
183
183
Staphylococcus Aureus
181
181
Ischemia
177
177
Edema
172
173
Foreign Body In Patient
167
167
Internal Organ Perforation
166
166
Cyst(s)
146
146
Depression
143
143
Numbness
139
139
Reaction
137
138
Anxiety
122
122
Hypersensitivity/Allergic reaction
119
120
Ulcer
115
115
No Known Impact Or Consequence To Patient
115
115
Urinary Frequency
114
114
Tissue Damage
112
115
Fatigue
111
111
Cramp(s) /Muscle Spasm(s)
108
108
Rash
98
98
Micturition Urgency
96
96
Skin Inflammation/ Irritation
95
95
Hematuria
93
93
Peritonitis
89
89
Dysuria
87
87
Weakness
81
81
Tachycardia
77
77
Ambulation Difficulties
75
75
Neuropathy
73
73
Low Blood Pressure/ Hypotension
70
71
Abnormal Vaginal Discharge
66
66
Sleep Dysfunction
65
65
Corneal Pannus
62
62
Itching Sensation
58
58
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
Sofradim Production
II
Apr-26-2018
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