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TPLC
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show TPLC since
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Device
mesh, surgical
Regulation Description
Surgical mesh.
Product Code
FTM
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALAFAIR BIOSCIENCES INC
SUBSTANTIALLY EQUIVALENT
3
AROA BIOSURGERY LTD.
SUBSTANTIALLY EQUIVALENT
1
AZIYO BIOLOGICS, INC.
SUBSTANTIALLY EQUIVALENT
1
B. BRUAN SURGICAL, SA
SUBSTANTIALLY EQUIVALENT
1
COOK BIOTECH INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
ELUTIA INC.
SUBSTANTIALLY EQUIVALENT
1
GEISTLICH PHARMA AG
SUBSTANTIALLY EQUIVALENT
1
SYNOVIS LIFE TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
SYNOVIS LIFE TECHNOLOGIES. INC. (A SUBSIDIARY OF BAXTER
SUBSTANTIALLY EQUIVALENT
1
TELA BIO
SUBSTANTIALLY EQUIVALENT
1
TELA BIO, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
458
458
2021
369
369
2022
375
375
2023
486
486
2024
383
383
2025
140
140
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1641
1641
Patient Device Interaction Problem
145
145
Insufficient Information
127
127
Defective Device
105
105
Break
89
89
Patient-Device Incompatibility
66
66
Migration or Expulsion of Device
60
60
Migration
33
33
No Apparent Adverse Event
23
23
Mechanics Altered
22
22
Material Disintegration
21
21
Degraded
21
21
Peeled/Delaminated
17
17
Material Split, Cut or Torn
16
16
Material Integrity Problem
15
15
Off-Label Use
10
10
Fluid/Blood Leak
9
9
Appropriate Term/Code Not Available
9
9
Detachment of Device or Device Component
8
8
Tear, Rip or Hole in Device Packaging
8
8
Improper or Incorrect Procedure or Method
7
7
Material Deformation
7
7
Therapeutic or Diagnostic Output Failure
6
6
Contamination /Decontamination Problem
5
5
Compatibility Problem
4
4
Contamination
3
3
Malposition of Device
3
3
Material Separation
3
3
Device Appears to Trigger Rejection
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Discolored
2
2
Material Too Rigid or Stiff
2
2
Use of Device Problem
2
2
Material Twisted/Bent
2
2
Device Damaged Prior to Use
2
2
Product Quality Problem
2
2
Entrapment of Device
2
2
Melted
1
1
Unexpected Therapeutic Results
1
1
Failure to Form Staple
1
1
Fracture
1
1
Difficult to Open or Close
1
1
Failure to Seal
1
1
Material Protrusion/Extrusion
1
1
Device Contamination with Chemical or Other Material
1
1
Inadequacy of Device Shape and/or Size
1
1
Material Rupture
1
1
Material Perforation
1
1
Shipping Damage or Problem
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hernia
936
936
Adhesion(s)
401
401
Unspecified Infection
280
280
Pain
275
275
Injury
216
216
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
190
190
Seroma
190
190
Unspecified Tissue Injury
183
183
Obstruction/Occlusion
159
159
Abscess
153
153
No Clinical Signs, Symptoms or Conditions
149
149
Insufficient Information
142
142
Bacterial Infection
140
140
Fistula
120
120
Impaired Healing
97
97
Inflammation
85
85
Necrosis
85
85
Fluid Discharge
82
82
Wound Dehiscence
75
75
Failure of Implant
69
69
Erosion
67
67
Hemorrhage/Bleeding
67
67
Abdominal Pain
65
65
Post Operative Wound Infection
65
65
No Code Available
61
61
Scar Tissue
51
51
Discomfort
46
46
Purulent Discharge
43
43
Hematoma
43
43
Foreign Body Reaction
40
40
Perforation
38
38
Fever
34
34
Sepsis
32
32
Abdominal Distention
30
30
Cellulitis
28
28
Erythema
25
25
Incontinence
23
23
Hypersensitivity/Allergic reaction
22
22
Swelling/ Edema
21
21
Urinary Tract Infection
20
20
Nausea
20
20
Capsular Contracture
19
19
Vomiting
19
19
Ascites
17
17
Fibrosis
17
17
Emotional Changes
15
15
Scarring
15
15
Stenosis
14
14
Discharge
14
14
Prolapse
14
14
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Mar-26-2024
2
Baxter Healthcare Corporation
II
Jan-05-2024
3
Baxter Healthcare Corporation
II
Jan-08-2021
4
Cook Biotech, Inc.
II
Sep-25-2024
5
Stryker Leibinger GmbH & Co. KG
II
Mar-03-2022
6
TEI Biosciences, Inc.
II
Sep-30-2024
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