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TPLC
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Device
suture, nonabsorbable, synthetic, polyamide
Product Code
GAR
Regulation Number
878.5020
Device Class
2
Premarket Reviews
Manufacturer
Decision
AESCULAP, INC.
SUBSTANTIALLY EQUIVALENT
1
ANTARMA LLC DBA GOLNIT SUTURES
SUBSTANTIALLY EQUIVALENT
1
KONO SEISAKUSHO CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
RIVERPOINT MEDICAL
SUBSTANTIALLY EQUIVALENT
1
SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SM ENG CO., LTD
SUBSTANTIALLY EQUIVALENT
1
TAS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
UNILENE S.A.C.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
100
100
2015
86
86
2016
123
123
2017
180
180
2018
541
541
2019
518
518
2020
383
383
2021
532
532
2022
546
546
2023
606
606
2024
189
189
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1833
1833
Material Separation
746
746
Adverse Event Without Identified Device or Use Problem
348
348
Detachment of Device or Device Component
220
220
Appropriate Term/Code Not Available
107
107
Material Split, Cut or Torn
74
74
Detachment Of Device Component
73
73
Device Markings/Labelling Problem
56
56
Manufacturing, Packaging or Shipping Problem
54
54
Dull, Blunt
49
49
Component Misassembled
49
49
Material Integrity Problem
47
47
Failure To Adhere Or Bond
41
41
Product Quality Problem
41
41
Defective Component
38
38
Reaction
24
24
Delivered as Unsterile Product
22
22
Patient-Device Incompatibility
21
21
Bent
20
20
Packaging Problem
20
20
Material Discolored
17
17
Device Operates Differently Than Expected
16
16
Device Misassembled During Manufacturing /Shipping
15
15
Other (for use when an appropriate device code cannot be identified)
15
15
Tear, Rip or Hole in Device Packaging
15
15
Positioning Failure
14
14
Component Incompatible
12
12
Unsealed Device Packaging
12
12
Material Twisted/Bent
11
11
Insufficient Information
11
11
Material Frayed
10
10
Inadequacy of Device Shape and/or Size
9
9
Component Missing
9
9
Device Contaminated During Manufacture or Shipping
7
7
Difficult to Open or Remove Packaging Material
5
5
Needle, separation
5
5
Crack
5
5
Fracture
4
4
Loss of or Failure to Bond
4
4
Device Or Device Fragments Location Unknown
4
4
Device Damaged Prior to Use
3
3
Unraveled Material
3
3
Material Fragmentation
3
3
Knotted
3
3
Difficult to Remove
3
3
Material Too Rigid or Stiff
2
2
Material Rupture
2
2
Nonstandard Device
2
2
Mechanical Problem
2
2
Migration or Expulsion of Device
2
2
Misassembled
2
2
Battery charger, defective
2
2
Incomplete or Missing Packaging
2
2
Contamination /Decontamination Problem
2
2
Material Deformation
2
2
Device Contamination with Chemical or Other Material
2
2
Patient Device Interaction Problem
2
2
Device Fell
1
1
Inaccurate Information
1
1
Missing Information
1
1
Unexpected Color
1
1
Incorrect Device Or Component Shipped
1
1
Mechanical Jam
1
1
Device Disinfection Or Sterilization Issue
1
1
Device Dislodged or Dislocated
1
1
Extrusion
1
1
Out-Of-Box Failure
1
1
Malposition of Device
1
1
Obstruction of Flow
1
1
Use of Device Problem
1
1
Fitting Problem
1
1
Unknown (for use when the device problem is not known)
1
1
Microbial Contamination of Device
1
1
Contamination
1
1
Kinked
1
1
Material Erosion
1
1
Device Expiration Issue
1
1
Poor Quality Image
1
1
Leak/Splash
1
1
Device Slipped
1
1
Occlusion Within Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1564
1564
No Consequences Or Impact To Patient
1144
1144
No Known Impact Or Consequence To Patient
388
388
Unspecified Infection
147
147
Insufficient Information
117
117
Wound Dehiscence
90
90
Not Applicable
81
81
No Code Available
66
66
Post Operative Wound Infection
63
63
Pain
45
45
Hemorrhage/Bleeding
41
41
Cerebrospinal Fluid Leakage
37
37
Thrombosis/Thrombus
36
36
Foreign Body In Patient
30
30
Hematoma
30
30
Erythema
29
29
Inflammation
26
26
Swelling
24
24
Treatment with medication(s)
22
22
No Information
22
22
Abscess
21
21
Reaction
20
20
No Patient Involvement
19
19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
18
18
Necrosis
17
17
Therapy/non-surgical treatment, additional
15
15
Surgical procedure
15
15
Seroma
14
14
Local Reaction
14
14
Scar Tissue
14
14
Swelling/ Edema
14
14
Low Blood Pressure/ Hypotension
13
13
Tachycardia
12
12
Transfusion of blood products
12
12
Drainage
12
12
Fluid Discharge
11
11
Unspecified Tissue Injury
11
11
Device Embedded In Tissue or Plaque
11
11
Hypersensitivity/Allergic reaction
11
11
Impaired Healing
10
10
Meningitis
10
10
Hernia
10
10
Unintended Radiation Exposure
9
9
Failure to Anastomose
9
9
Radiation Exposure, Unintended
8
8
Skin Irritation
8
8
Irritation
7
7
Sepsis
7
7
Tissue Damage
6
6
Granuloma
6
6
Headache
6
6
Injury
6
6
Discomfort
6
6
Obstruction/Occlusion
6
6
Nonresorbable materials, unretrieved in body
5
5
Other (for use when an appropriate patient code cannot be identified)
5
5
Blood Loss
5
5
Fever
5
5
Fistula
5
5
Foreign Body Reaction
5
5
Scarring
5
5
Itching Sensation
5
5
Edema
4
4
Purulent Discharge
4
4
Surgical procedure, additional
4
4
Visual Disturbances
4
4
Numbness
4
4
Vomiting
3
3
Unknown (for use when the patient's condition is not known)
3
3
Skin Inflammation/ Irritation
3
3
Hearing Impairment
3
3
Conjunctivitis
3
3
Cellulitis
3
3
Nerve Damage
3
3
Hyperemia
3
3
Incontinence
3
3
Paralysis
3
3
Nausea
3
3
Thrombosis
2
2
Hyphema
2
2
Intraocular Pressure Increased
2
2
Laceration(s)
2
2
Muscle Spasm(s)
2
2
Bleeding
2
2
Erosion
2
2
Abdominal Pain
2
2
Foreign Body Sensation in Eye
2
2
Cyst(s)
2
2
Eye Injury
2
2
Urinary Tract Infection
2
2
Visual Impairment
2
2
Loss of Vision
2
2
Burning Sensation
2
2
Complaint, Ill-Defined
2
2
Hypoesthesia
1
1
Distress
1
1
Neck Pain
1
1
Non-union Bone Fracture
1
1
Joint Dislocation
1
1
Abnormal Vaginal Discharge
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap, Inc.
II
Jul-09-2014
2
C P Medical Inc.
II
Sep-09-2011
3
Covidien LP
II
Jan-29-2024
4
Covidien, LP
II
Feb-25-2023
5
Riverpoint Medical, LLC
II
Sep-08-2016
6
Teleflex Medical
II
May-07-2014
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