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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
2
ALAFAIR BIOSCIENCES INC
SUBSTANTIALLY EQUIVALENT
3
AROA BIOSURGERY LTD.
SUBSTANTIALLY EQUIVALENT
1
AZIYO BIOLOGICS, INC.
SUBSTANTIALLY EQUIVALENT
4
B. BRUAN SURGICAL, SA
SUBSTANTIALLY EQUIVALENT
1
COLORADO THERAPEUTICS LLC
SUBSTANTIALLY EQUIVALENT
1
COOK BIOTECH INCORPORATED
SUBSTANTIALLY EQUIVALENT
4
CURASEAL, INC.
SUBSTANTIALLY EQUIVALENT
1
GEISTLICH PHARMA AG
SUBSTANTIALLY EQUIVALENT
1
LIFECELL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MIROMATRIX MEDICAL 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
TEI BIOSCIENCES INC.
SUBSTANTIALLY EQUIVALENT
1
TISGENX
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
529
529
2018
356
356
2019
417
417
2020
460
460
2021
373
373
2022
205
205
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1415
1415
Appropriate Term/Code Not Available
418
418
Insufficient Information
167
167
Migration or Expulsion of Device
137
137
Patient Device Interaction Problem
120
120
Defective Device
73
73
Patient-Device Incompatibility
57
57
Migration
51
51
Degraded
34
34
Material Erosion
29
29
Material Split, Cut or Torn
28
28
Material Integrity Problem
26
26
Loss of or Failure to Bond
21
21
Device Operates Differently Than Expected
19
19
Break
14
14
Material Perforation
14
14
Detachment of Device or Device Component
14
14
Mechanics Altered
13
13
Material Deformation
12
12
Product Quality Problem
10
10
Microbial Contamination of Device
7
7
Device Appears to Trigger Rejection
6
6
Contamination
6
6
Material Disintegration
6
6
Device Contamination With Biological Material
5
5
Therapeutic or Diagnostic Output Failure
5
5
No Apparent Adverse Event
5
5
Improper or Incorrect Procedure or Method
4
4
Material Fragmentation
4
4
Off-Label Use
3
3
Leak/Splash
3
3
Peeled/Delaminated
3
3
Split
3
3
Fluid Leak
3
3
Entrapment of Device
3
3
Biocompatibility
3
3
Shelf Life Exceeded
2
2
Delamination
2
2
Difficult to Open or Close
2
2
Use of Device Problem
2
2
Failure To Adhere Or Bond
2
2
Fitting Problem
2
2
Detachment Of Device Component
2
2
Unexpected Therapeutic Results
2
2
Fracture
2
2
Material Protrusion/Extrusion
2
2
Hole In Material
1
1
Device Packaging Compromised
1
1
Expulsion
1
1
Air Leak
1
1
Calcified
1
1
Material Too Rigid or Stiff
1
1
Material Separation
1
1
Radiation Overexposure
1
1
Unintended Movement
1
1
Physical Resistance/Sticking
1
1
Device Contamination with Body Fluid
1
1
Tear, Rip or Hole in Device Packaging
1
1
Clumping in Device or Device Ingredient
1
1
Noise, Audible
1
1
Device Dislodged or Dislocated
1
1
Torn Material
1
1
Shipping Damage or Problem
1
1
Melted
1
1
Device Expiration Issue
1
1
Contamination /Decontamination Problem
1
1
Extrusion
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Disconnection
1
1
Material Rupture
1
1
Malposition of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
608
608
Hernia
564
564
No Code Available
559
559
Pain
438
438
Unspecified Infection
420
420
Adhesion(s)
347
347
Seroma
202
202
Erosion
150
150
Abscess
146
146
Unspecified Tissue Injury
137
137
Impaired Healing
123
123
Obstruction/Occlusion
112
112
Fistula
109
110
Abdominal Pain
106
107
Necrosis
106
106
Not Applicable
106
106
Inflammation
98
98
Purulent Discharge
83
83
Failure of Implant
83
83
Bacterial Infection
81
81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
74
74
Wound Dehiscence
66
66
Insufficient Information
66
66
Hematoma
59
59
Discharge
59
59
Fluid Discharge
56
56
Post Operative Wound Infection
56
56
Scar Tissue
55
55
Abdominal Distention
53
53
Discomfort
50
50
Incontinence
48
48
Ascites
44
44
Sepsis
44
44
Nausea
43
43
Foreign Body Reaction
42
42
Fever
42
42
No Consequences Or Impact To Patient
39
39
Scarring
39
39
Urinary Tract Infection
39
39
Hemorrhage/Bleeding
38
38
Blood Loss
36
36
Vomiting
34
34
Erythema
29
29
Cellulitis
28
28
Fibrosis
25
25
No Known Impact Or Consequence To Patient
23
23
Swelling
22
22
Prolapse
21
21
Capsular Contracture
21
21
No Clinical Signs, Symptoms or Conditions
19
19
Hypersensitivity/Allergic reaction
19
19
Urinary Retention
19
19
Disability
18
18
Constipation
16
16
Bowel Perforation
16
16
Calcium Deposits/Calcification
16
16
Perforation
15
15
Abnormal Vaginal Discharge
14
14
No Information
13
13
Death
13
13
Emotional Changes
13
13
Ambulation Difficulties
13
13
Granuloma
13
13
Diarrhea
13
13
Nerve Damage
13
13
Fatigue
10
10
Staphylococcus Aureus
9
9
Ischemia
9
9
Tachycardia
9
9
Edema
9
9
Necrosis Of Flap Tissue
8
8
Swelling/ Edema
8
8
Respiratory Failure
8
8
Burning Sensation
8
8
Ulcer
8
8
Excessive Tear Production
8
8
Deformity/ Disfigurement
7
7
Muscle Weakness
7
7
Dysphagia/ Odynophagia
7
7
Peritonitis
7
7
Urinary Frequency
7
7
Micturition Urgency
7
7
Local Reaction
6
6
Foreign Body In Patient
6
6
Ulceration
6
6
Renal Failure
6
6
Failure to Anastomose
6
6
Anemia
6
6
Fungal Infection
6
6
Complaint, Ill-Defined
6
6
Depression
6
6
Pocket Erosion
6
6
Headache
5
5
Eye Injury
5
5
Corneal Pannus
5
5
Rash
5
5
Low Blood Pressure/ Hypotension
5
5
Thrombosis
5
5
Cramp(s)
5
5
Patient Problem/Medical Problem
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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