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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
3
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
LNTEGRA LIFESCIENCES
SUBSTANTIALLY EQUIVALENT
1
MAST BIOSURGERY
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
4
PROXY BIOMEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
SOFRADIM PRODUCTION
SUBSTANTIALLY EQUIVALENT
5
XIROS LTD
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2018
11885
11885
2019
21721
21721
2020
18816
18816
2021
16284
16284
2022
11439
11439
2023
5302
5302
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Device
48435
48435
Insufficient Information
31609
31609
Adverse Event Without Identified Device or Use Problem
28623
28623
Patient Device Interaction Problem
21484
21484
Migration or Expulsion of Device
4193
4193
Mechanics Altered
3961
3961
Appropriate Term/Code Not Available
2109
2109
Patient-Device Incompatibility
1559
1559
Material Deformation
994
994
Material Split, Cut or Torn
786
786
Material Integrity Problem
603
603
Loss of or Failure to Bond
508
508
Material Erosion
417
417
Migration
392
392
Degraded
337
337
Detachment of Device or Device Component
278
278
Material Perforation
134
134
No Apparent Adverse Event
124
124
Material Separation
102
102
Break
96
96
Therapeutic or Diagnostic Output Failure
92
92
Material Protrusion/Extrusion
89
89
Product Quality Problem
76
76
Use of Device Problem
64
64
Microbial Contamination of Device
58
58
Expiration Date Error
55
55
Contamination
50
50
Device Markings/Labelling Problem
49
49
Device Operates Differently Than Expected
45
45
Delivered as Unsterile Product
38
38
Improper or Incorrect Procedure or Method
38
38
Material Twisted/Bent
35
35
Device Contamination with Chemical or Other Material
31
31
Packaging Problem
31
31
Tear, Rip or Hole in Device Packaging
29
29
Material Disintegration
26
26
Torn Material
24
24
Output Problem
23
23
Device Dislodged or Dislocated
23
23
Defective Component
21
21
Entrapment of Device
21
21
Material Frayed
21
21
Device Appears to Trigger Rejection
20
20
Unexpected Therapeutic Results
19
19
Structural Problem
19
19
Peeled/Delaminated
14
14
Loosening of Implant Not Related to Bone-Ingrowth
14
14
Physical Resistance/Sticking
14
14
Unsealed Device Packaging
13
13
Difficult to Remove
13
13
Deformation Due to Compressive Stress
12
12
Material Fragmentation
11
11
Failure to Osseointegrate
11
11
Off-Label Use
11
11
Material Puncture/Hole
11
11
Detachment Of Device Component
11
11
Failure To Adhere Or Bond
10
10
Nonstandard Device
9
9
Contamination /Decontamination Problem
9
9
Folded
9
9
Extrusion
9
9
Human-Device Interface Problem
8
8
Unintended Movement
8
8
Loose or Intermittent Connection
8
8
Device Expiration Issue
8
8
Shelf Life Exceeded
7
7
Malposition of Device
7
7
Expulsion
6
6
Difficult to Open or Close
6
6
Retraction Problem
6
6
Device Slipped
6
6
Unraveled Material
6
6
Component Missing
6
6
Obstruction of Flow
6
6
Difficult to Insert
6
6
Sticking
5
5
Device Contaminated During Manufacture or Shipping
5
5
Device Damaged by Another Device
5
5
Positioning Problem
4
4
Protective Measures Problem
4
4
Inadequacy of Device Shape and/or Size
4
4
Material Too Rigid or Stiff
4
4
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Mechanical Problem
4
4
Hole In Material
3
3
Inflation Problem
3
3
Fracture
3
3
Crack
3
3
Material Rupture
3
3
Failure to Unfold or Unwrap
3
3
Device-Device Incompatibility
3
3
Compatibility Problem
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Biocompatibility
2
2
Device Difficult to Maintain
2
2
Component Misassembled
2
2
Device Fell
2
2
Lack of Effect
2
2
Difficult or Delayed Positioning
2
2
Disconnection
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
44260
44270
Injury
40947
40948
Insufficient Information
19236
19236
Hernia
19228
19233
Disability
17374
17374
Adhesion(s)
16921
16930
Unspecified Tissue Injury
10208
10208
Unspecified Infection
9338
9345
Inflammation
8027
8030
No Code Available
4868
4871
Scar Tissue
4419
4419
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4360
4360
Emotional Changes
4333
4334
Abdominal Pain
4021
4024
Obstruction/Occlusion
4002
4002
Abscess
3531
3533
Discomfort
3371
3372
Nausea
2946
2947
Seroma
2794
2797
Not Applicable
2763
2763
Erosion
1977
1980
Fistula
1950
1955
Scarring
1587
1589
Impaired Healing
1577
1580
Purulent Discharge
1409
1409
Abdominal Distention
1409
1409
Failure of Implant
1389
1390
Fluid Discharge
1349
1349
No Clinical Signs, Symptoms or Conditions
1329
1329
Foreign Body Reaction
1313
1315
Diarrhea
1260
1260
Nerve Damage
1135
1137
Hematoma
1125
1125
Chills
1064
1064
Necrosis
1022
1022
Decreased Appetite
1020
1020
Distress
982
982
Swelling/ Edema
929
929
Weight Changes
897
897
Ascites
896
896
Fibrosis
824
824
Discharge
799
799
Hemorrhage/Bleeding
799
799
Vomiting
750
751
Deformity/ Disfigurement
646
646
Bacterial Infection
622
622
Swelling
571
571
No Information
562
562
Fever
521
521
Perforation
502
502
Blood Loss
472
472
Wound Dehiscence
433
433
Constipation
423
423
Erythema
407
407
No Consequences Or Impact To Patient
387
387
Cellulitis
378
378
Muscle Weakness
366
366
Nodule
352
352
Incontinence
336
336
Granuloma
335
336
Sepsis
293
294
Urinary Tract Infection
292
292
Bowel Perforation
251
251
Urinary Retention
250
250
Post Operative Wound Infection
239
240
Prolapse
237
237
Depression
211
211
Burning Sensation
207
207
Numbness
194
194
Ischemia
187
187
Anxiety
184
184
Death
183
183
Staphylococcus Aureus
181
181
Hypersensitivity/Allergic reaction
177
178
Edema
172
173
Cyst(s)
171
171
Internal Organ Perforation
170
170
Foreign Body In Patient
170
170
Ulcer
147
147
Cramp(s) /Muscle Spasm(s)
143
143
Reaction
137
138
Fatigue
129
129
Urinary Frequency
128
128
Ambulation Difficulties
124
124
Rash
117
117
No Known Impact Or Consequence To Patient
115
115
Tissue Damage
112
115
Micturition Urgency
104
104
Dysuria
104
104
Skin Inflammation/ Irritation
104
104
Tachycardia
99
99
Sexual Dysfunction
95
95
Hematuria
95
95
Peritonitis
94
94
Neuropathy
85
85
Sleep Dysfunction
85
85
Pneumonia
82
82
Weakness
81
81
Low Blood Pressure/ Hypotension
81
82
Thrombosis/Thrombus
80
80
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
Covidien, LP
II
Feb-27-2023
6
Davol, Inc.
II
Jul-27-2023
7
Ethicon, Inc.
II
Dec-03-2020
8
Sofradim Production
II
Apr-26-2018
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