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TPLC
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show TPLC since
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Device
suture, absorbable, synthetic, polyglycolic acid
Product Code
GAM
Regulation Number
878.4493
Device Class
2
Premarket Reviews
Manufacturer
Decision
ETHICON INC.
SUBSTANTIALLY EQUIVALENT
1
ETHICON, INC
SUBSTANTIALLY EQUIVALENT
1
ETHICON, INC.
SUBSTANTIALLY EQUIVALENT
3
FOOSIN MEDICAL SUPPLIES INC., LTD
SUBSTANTIALLY EQUIVALENT
2
ORIGAMI SURGICAL
SUBSTANTIALLY EQUIVALENT
1
ORIGAMI SURGICAL INC .
SUBSTANTIALLY EQUIVALENT
2
ORIGAMI SURGICAL LLC
SUBSTANTIALLY EQUIVALENT
1
RESORBA MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
RK MANUFACTURING CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SAMYANG HOLDINGS CORP., LTD.
SUBSTANTIALLY EQUIVALENT
1
SILHOUETTE LIFT INC.
SUBSTANTIALLY EQUIVALENT
1
SM ENG CO., LTD
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
2228
3465
2019
3564
4679
2020
3414
3414
2021
4504
4870
2022
4813
5545
2023
3954
3954
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
8702
11277
Material Separation
4769
4790
Detachment of Device or Device Component
4121
4121
Adverse Event Without Identified Device or Use Problem
2790
3278
Material Integrity Problem
593
593
Material Frayed
346
346
Appropriate Term/Code Not Available
328
328
Patient-Device Incompatibility
321
321
Material Split, Cut or Torn
256
256
Unraveled Material
247
247
Manufacturing, Packaging or Shipping Problem
217
339
Device Markings/Labelling Problem
210
210
Insufficient Information
156
156
Component Missing
146
146
Material Twisted/Bent
112
112
Tear, Rip or Hole in Device Packaging
109
109
Product Quality Problem
109
109
Patient Device Interaction Problem
108
108
Detachment Of Device Component
105
105
Component Misassembled
98
98
Dull, Blunt
86
86
Human-Device Interface Problem
82
82
Positioning Failure
69
69
Loss of or Failure to Bond
68
68
Mechanical Problem
67
67
Packaging Problem
63
63
Difficult to Open or Remove Packaging Material
62
62
Delivered as Unsterile Product
58
58
Defective Component
52
52
Device Operates Differently Than Expected
45
45
Use of Device Problem
42
42
Device Slipped
41
41
Device Appears to Trigger Rejection
40
40
Component or Accessory Incompatibility
35
35
Device Contaminated During Manufacture or Shipping
35
35
Component Incompatible
33
33
Fracture
32
32
Material Fragmentation
29
29
Loose or Intermittent Connection
26
148
Difficult to Remove
24
24
Degraded
24
24
Material Deformation
22
22
Device Misassembled During Manufacturing /Shipping
20
20
Entrapment of Device
19
19
Extrusion
18
18
Material Protrusion/Extrusion
14
14
Failure To Adhere Or Bond
14
14
Nonstandard Device
13
13
Positioning Problem
13
13
Device Contamination with Chemical or Other Material
11
11
Device Packaging Compromised
11
11
Material Too Soft/Flexible
11
11
Defective Device
11
11
Material Disintegration
11
11
Inadequacy of Device Shape and/or Size
10
10
Device Fell
10
254
Separation Problem
9
9
Difficult to Open or Close
9
9
No Apparent Adverse Event
9
9
Bent
9
9
Material Erosion
9
9
Material Discolored
9
9
Device Issue
8
8
Biocompatibility
8
8
Contamination /Decontamination Problem
7
7
Mechanics Altered
7
7
Migration
6
6
Failure to Fire
6
6
Malposition of Device
6
6
Separation Failure
5
5
Leak/Splash
5
5
Unsealed Device Packaging
5
5
Inaccurate Information
5
5
Compatibility Problem
5
5
Device Dislodged or Dislocated
5
5
Therapeutic or Diagnostic Output Failure
4
4
Physical Property Issue
4
4
Missing Information
4
4
Sharp Edges
3
3
Disconnection
3
3
Fluid/Blood Leak
3
3
Difficult or Delayed Positioning
3
3
Cross Reactivity
3
3
Contamination
3
3
Device Damaged Prior to Use
3
3
Structural Problem
3
3
Material Too Rigid or Stiff
3
3
Material Puncture/Hole
3
3
Improper or Incorrect Procedure or Method
2
2
Material Rupture
2
2
Obstruction of Flow
2
2
Out-Of-Box Failure
2
2
Failure to Form Staple
2
2
Expiration Date Error
2
2
Migration or Expulsion of Device
2
2
Misassembled
2
2
Physical Resistance/Sticking
2
2
Expulsion
2
2
Difficult to Advance
2
2
Deformation Due to Compressive Stress
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
10551
10795
No Consequences Or Impact To Patient
4546
6898
No Known Impact Or Consequence To Patient
1478
1478
Wound Dehiscence
1244
1244
Insufficient Information
1014
1014
Unspecified Infection
807
929
No Code Available
791
791
Not Applicable
752
752
Pain
513
635
Post Operative Wound Infection
494
616
Inflammation
480
480
Foreign Body In Patient
359
481
Impaired Healing
308
430
No Patient Involvement
292
292
Hemorrhage/Bleeding
283
527
Unspecified Tissue Injury
280
280
Unintended Radiation Exposure
228
228
Abscess
220
220
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
217
217
Hematoma
207
207
Seroma
168
168
No Information
167
167
Erythema
162
162
Blood Loss
153
153
Fluid Discharge
144
144
Hernia
135
135
Failure to Anastomose
133
377
Radiation Exposure, Unintended
133
133
Necrosis
128
128
Pocket Erosion
118
118
Granuloma
113
113
Swelling
111
111
Purulent Discharge
110
110
Swelling/ Edema
108
108
Fistula
101
101
Foreign Body Reaction
98
98
Obstruction/Occlusion
95
95
Fever
93
93
Scar Tissue
89
89
Device Embedded In Tissue or Plaque
89
89
Hypersensitivity/Allergic reaction
87
87
Cellulitis
66
66
Skin Inflammation/ Irritation
66
66
Urinary Tract Infection
64
64
Tissue Damage
63
63
Discomfort
63
63
Reaction
56
56
Incontinence
54
54
Local Reaction
47
47
Injury
40
40
Patient Problem/Medical Problem
39
39
Sepsis
39
39
Irritation
38
38
Urinary Retention
37
37
Bacterial Infection
36
36
Erosion
34
34
Itching Sensation
32
32
Eye Injury
31
31
Adhesion(s)
29
29
Abdominal Pain
25
25
Edema
24
24
Organ Dehiscence
24
24
Laceration(s)
21
21
Abnormal Vaginal Discharge
21
21
Scarring
20
20
Rash
19
19
Peritonitis
19
19
Skin Irritation
18
18
Stenosis
17
17
Skin Erosion
16
16
Ulcer
15
15
Hematuria
15
15
Eye Infections
15
15
Vomiting
14
14
Blurred Vision
13
13
Blister
13
13
Skin Infection
12
12
Tissue Breakdown
12
12
Failure of Implant
12
12
Death
11
11
Perforation
11
11
Nerve Damage
11
11
Visual Impairment
10
10
Thrombosis
10
10
Chills
10
10
Cyst(s)
10
10
Cerebrospinal Fluid Leakage
10
10
Anxiety
10
10
Ptosis
9
9
Anemia
9
9
Visual Disturbances
8
8
Fibrosis
8
8
Skin Inflammation
8
8
Bowel Perforation
7
7
Shock
7
7
Septic Shock
6
6
Staphylococcus Aureus
6
6
Burning Sensation
6
6
Diarrhea
6
6
Dysphagia/ Odynophagia
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
CP Medical Inc
II
Dec-06-2019
2
Covidien LLC
II
Feb-19-2020
3
Covidien LLC
II
Aug-03-2018
4
Covidien, LP
II
Nov-11-2022
5
Ethicon, Inc.
II
Oct-31-2022
6
Ethicon, Inc.
II
May-10-2022
7
Ethicon, Inc.
II
Oct-16-2020
8
Ethicon, Inc.
II
Feb-04-2020
9
Ethicon, Inc.
II
Apr-12-2019
10
Ethicon, Inc.
II
Feb-23-2018
11
Gordian Surgical
II
Nov-03-2020
12
Riverpoint Medical, LLC
II
Feb-03-2021
13
Riverpoint Medical, LLC
II
Oct-01-2020
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