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TPLC
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show TPLC since
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Device
mesh, surgical
Product Code
FTM
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACELL, INC.
SUBSTANTIALLY EQUIVALENT
1
ALAFAIR BIOSCIENCES INC
SUBSTANTIALLY EQUIVALENT
3
AROA BIOSURGERY LTD.
SUBSTANTIALLY EQUIVALENT
1
AZIYO BIOLOGICS, INC.
SUBSTANTIALLY EQUIVALENT
3
B. BRUAN SURGICAL, SA
SUBSTANTIALLY EQUIVALENT
1
COOK BIOTECH INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
GEISTLICH PHARMA AG
SUBSTANTIALLY EQUIVALENT
1
SYNOVIS LIFE TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
SYNOVIS LIFE TECHNOLOGIES, INC. (BAXTER INTERNATIONAL INC.)
SUBSTANTIALLY EQUIVALENT
1
SYNOVIS LIFE TECHNOLOGIES. INC. (A SUBSIDIARY OF BAXTER
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA) PRODUCTS LLC
SUBSTANTIALLY EQUIVALENT
1
TELA BIO
SUBSTANTIALLY EQUIVALENT
1
TISGENX
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
356
356
2019
417
417
2020
460
460
2021
373
373
2022
377
377
2023
210
210
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1546
1546
Patient Device Interaction Problem
153
153
Insufficient Information
147
147
Migration or Expulsion of Device
116
116
Defective Device
94
94
Appropriate Term/Code Not Available
93
93
Break
83
83
Patient-Device Incompatibility
71
71
Migration
53
53
Degraded
33
33
Material Split, Cut or Torn
29
29
Material Integrity Problem
27
27
Material Erosion
27
27
Mechanics Altered
18
18
Loss of or Failure to Bond
17
17
Peeled/Delaminated
15
15
Material Perforation
14
14
Detachment of Device or Device Component
14
14
Material Deformation
9
9
No Apparent Adverse Event
9
9
Contamination
7
7
Material Disintegration
7
7
Product Quality Problem
7
7
Device Appears to Trigger Rejection
6
6
Therapeutic or Diagnostic Output Failure
5
5
Device Operates Differently Than Expected
4
4
Contamination /Decontamination Problem
4
4
Entrapment of Device
4
4
Improper or Incorrect Procedure or Method
4
4
Off-Label Use
3
3
Biocompatibility
3
3
Fluid/Blood Leak
3
3
Material Protrusion/Extrusion
3
3
Manufacturing, Packaging or Shipping Problem
2
2
Difficult to Open or Close
2
2
Fracture
2
2
Material Fragmentation
2
2
Leak/Splash
2
2
Shelf Life Exceeded
2
2
Shipping Damage or Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Unexpected Therapeutic Results
1
1
Use of Device Problem
1
1
Malposition of Device
1
1
Microbial Contamination of Device
1
1
Device Contamination with Body Fluid
1
1
Tear, Rip or Hole in Device Packaging
1
1
Expiration Date Error
1
1
Melted
1
1
Material Too Rigid or Stiff
1
1
Material Rupture
1
1
Material Separation
1
1
Material Discolored
1
1
Disconnection
1
1
Failure To Adhere Or Bond
1
1
Calcified
1
1
Device Dislodged or Dislocated
1
1
Expulsion
1
1
Extrusion
1
1
Material Twisted/Bent
1
1
Unintended Movement
1
1
Physical Resistance/Sticking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hernia
707
707
Injury
568
568
Pain
424
424
Unspecified Infection
387
387
Adhesion(s)
337
337
No Code Available
212
212
Seroma
198
198
Unspecified Tissue Injury
172
172
Abscess
148
148
Erosion
127
127
Obstruction/Occlusion
124
124
Impaired Healing
121
121
Inflammation
115
115
Fistula
114
115
Insufficient Information
107
107
Abdominal Pain
105
106
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
104
104
Necrosis
103
103
No Clinical Signs, Symptoms or Conditions
98
98
Not Applicable
90
90
Bacterial Infection
88
88
Purulent Discharge
86
86
Failure of Implant
80
80
Wound Dehiscence
69
69
Fluid Discharge
67
67
Scar Tissue
63
63
Abdominal Distention
56
56
Hematoma
55
55
Discharge
54
54
Hemorrhage/Bleeding
53
53
Discomfort
52
52
Incontinence
46
46
Post Operative Wound Infection
46
46
Foreign Body Reaction
45
45
Nausea
43
43
Ascites
43
43
Fever
42
42
Sepsis
42
42
Scarring
38
38
Urinary Tract Infection
38
38
Vomiting
33
33
Erythema
31
31
Cellulitis
29
29
Blood Loss
29
29
Perforation
27
27
Fibrosis
26
26
Prolapse
23
23
Capsular Contracture
21
21
Hypersensitivity/Allergic reaction
21
21
Urinary Retention
19
19
Swelling
19
19
Bowel Perforation
19
19
Swelling/ Edema
18
18
Emotional Changes
18
18
No Consequences Or Impact To Patient
17
17
Disability
17
17
Granuloma
16
16
No Known Impact Or Consequence To Patient
16
16
Constipation
16
16
Nerve Damage
15
15
Abnormal Vaginal Discharge
14
14
Diarrhea
14
14
Calcium Deposits/Calcification
14
14
Muscle Weakness
13
13
Death
11
11
Ambulation Difficulties
11
11
Fungal Infection
11
11
Dysphagia/ Odynophagia
10
10
Micturition Urgency
10
10
Deformity/ Disfigurement
10
10
Urinary Frequency
10
10
Ulcer
9
9
Depression
9
9
Tachycardia
9
9
Edema
9
9
No Information
9
9
Device Embedded In Tissue or Plaque
8
8
Fatigue
8
8
Ischemia
8
8
Excessive Tear Production
8
8
Staphylococcus Aureus
7
7
Anemia
7
7
Respiratory Failure
7
7
Foreign Body In Patient
7
7
Skin Inflammation/ Irritation
6
6
Local Reaction
6
6
Peritonitis
6
6
Chills
6
6
Burning Sensation
5
5
Pocket Erosion
5
5
Necrosis Of Flap Tissue
5
5
Internal Organ Perforation
5
5
Thrombosis
5
5
Ulceration
5
5
Corneal Pannus
5
5
Failure to Anastomose
5
5
Low Blood Pressure/ Hypotension
5
5
Eye Injury
5
5
Nodule
5
5
Dyspareunia
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
ACell, Inc
II
Mar-21-2019
2
AROA Biosurgery, LTD.
II
Nov-09-2018
3
AZIYO BIOLOGICS
II
Oct-04-2019
4
Baxter Healthcare Corporation
II
Jan-08-2021
5
Stryker Leibinger GmbH & Co. KG
II
Mar-03-2022
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