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TPLC
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show TPLC since
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2024
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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
2
B. BRUAN SURGICAL, SA
SUBSTANTIALLY EQUIVALENT
1
COOK BIOTECH INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
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
2019
416
416
2020
457
457
2021
369
369
2022
375
375
2023
485
485
2024
110
110
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1665
1665
Patient Device Interaction Problem
158
158
Insufficient Information
143
143
Defective Device
99
99
Migration or Expulsion of Device
92
92
Break
89
89
Patient-Device Incompatibility
60
60
Migration
47
47
Material Integrity Problem
28
28
Degraded
27
27
Material Split, Cut or Torn
24
24
Mechanics Altered
21
21
Material Erosion
18
18
Peeled/Delaminated
16
16
Loss of or Failure to Bond
16
16
Material Perforation
13
13
Detachment of Device or Device Component
13
13
Material Deformation
10
10
No Apparent Adverse Event
10
10
Material Disintegration
9
9
Appropriate Term/Code Not Available
8
8
Tear, Rip or Hole in Device Packaging
7
7
Off-Label Use
6
6
Fluid/Blood Leak
6
6
Therapeutic or Diagnostic Output Failure
6
6
Contamination /Decontamination Problem
5
5
Product Quality Problem
5
5
Device Appears to Trigger Rejection
5
5
Improper or Incorrect Procedure or Method
4
4
Material Separation
3
3
Entrapment of Device
3
3
Leak/Splash
2
2
Material Discolored
2
2
Contamination
2
2
Material Too Rigid or Stiff
2
2
Use of Device Problem
2
2
Device Damaged Prior to Use
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Protrusion/Extrusion
2
2
Material Twisted/Bent
1
1
Malposition of Device
1
1
Difficult to Open or Close
1
1
Device Dislodged or Dislocated
1
1
Expulsion
1
1
Device Contamination with Chemical or Other Material
1
1
Separation Problem
1
1
Defective Component
1
1
Device Contamination with Body Fluid
1
1
Expiration Date Error
1
1
Failure to Form Staple
1
1
Material Rupture
1
1
Shipping Damage or Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Unexpected Therapeutic Results
1
1
Disconnection
1
1
Fracture
1
1
Material Fragmentation
1
1
Melted
1
1
Material Puncture/Hole
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hernia
890
890
Injury
434
434
Adhesion(s)
377
377
Pain
359
359
Unspecified Infection
358
358
Unspecified Tissue Injury
201
201
Seroma
198
198
Abscess
167
167
No Code Available
149
149
Obstruction/Occlusion
131
131
Insufficient Information
126
126
No Clinical Signs, Symptoms or Conditions
125
125
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
124
124
Fistula
124
124
Impaired Healing
117
117
Bacterial Infection
116
116
Inflammation
112
112
Necrosis
101
101
Abdominal Pain
100
100
Erosion
86
86
Purulent Discharge
82
82
Fluid Discharge
81
81
Failure of Implant
72
72
Wound Dehiscence
66
66
Scar Tissue
63
63
Hemorrhage/Bleeding
59
59
Abdominal Distention
58
58
Discomfort
53
53
Hematoma
50
50
Foreign Body Reaction
49
49
Discharge
49
49
Ascites
44
44
Fever
41
41
Nausea
40
40
Sepsis
40
40
Post Operative Wound Infection
40
40
Not Applicable
37
37
Incontinence
35
35
Erythema
34
34
Scarring
32
32
Vomiting
29
29
Cellulitis
29
29
Fibrosis
29
29
Urinary Tract Infection
28
28
Perforation
28
28
Swelling/ Edema
26
26
Hypersensitivity/Allergic reaction
24
24
Capsular Contracture
22
22
Emotional Changes
21
21
Blood Loss
18
18
Bowel Perforation
18
18
Prolapse
18
18
Constipation
17
17
Granuloma
17
17
Muscle Weakness
15
15
Diarrhea
13
13
Urinary Retention
13
13
No Consequences Or Impact To Patient
13
13
Disability
12
12
No Known Impact Or Consequence To Patient
12
12
Fungal Infection
11
11
Depression
11
11
Distress
11
11
Calcium Deposits/Calcification
11
11
Micturition Urgency
11
11
Dysphagia/ Odynophagia
10
10
Death
10
10
Urinary Frequency
10
10
Swelling
10
10
Abnormal Vaginal Discharge
10
10
Skin Inflammation/ Irritation
10
10
Ambulation Difficulties
9
9
Edema
9
9
Anemia
8
8
Deformity/ Disfigurement
8
8
Ulcer
8
8
Device Embedded In Tissue or Plaque
8
8
Respiratory Failure
7
7
Nodule
7
7
Staphylococcus Aureus
7
7
Nerve Damage
7
7
Ischemia
7
7
Low Blood Pressure/ Hypotension
6
6
Fatigue
6
6
Local Reaction
6
6
Pocket Erosion
6
6
Tachycardia
6
6
Chills
6
6
Dyspareunia
6
6
Dysuria
6
6
Foreign Body In Patient
6
6
No Information
5
5
Weight Changes
5
5
Excessive Tear Production
5
5
Peritonitis
5
5
Thrombosis
5
5
Ulceration
5
5
Renal Failure
5
5
High Blood Pressure/ Hypertension
5
5
Failure to Anastomose
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
ACell, Inc
II
Mar-21-2019
2
AZIYO BIOLOGICS
II
Oct-04-2019
3
Baxter Healthcare Corporation
II
Mar-26-2024
4
Baxter Healthcare Corporation
II
Jan-05-2024
5
Baxter Healthcare Corporation
II
Jan-08-2021
6
Stryker Leibinger GmbH & Co. KG
II
Mar-03-2022
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