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TPLC
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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
2
FOOSIN MEDICAL SUPPLIES INC., LTD
SUBSTANTIALLY EQUIVALENT
2
ORIGAMI SURGICAL
SUBSTANTIALLY EQUIVALENT
1
ORIGAMI SURGICAL INC .
SUBSTANTIALLY EQUIVALENT
2
SAMYANG HOLDINGS CORP., LTD.
SUBSTANTIALLY EQUIVALENT
1
SILHOUETTE LIFT INC.
SUBSTANTIALLY EQUIVALENT
1
SM ENG CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
3564
4679
2020
3414
3414
2021
4504
4870
2022
4814
5546
2023
5072
5072
2024
1765
1765
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
9126
10464
Material Separation
5559
5580
Detachment of Device or Device Component
3986
3986
Adverse Event Without Identified Device or Use Problem
2873
3361
Material Integrity Problem
511
511
Material Frayed
365
365
Material Split, Cut or Torn
252
252
Patient-Device Incompatibility
230
230
Device Markings/Labelling Problem
215
215
Manufacturing, Packaging or Shipping Problem
213
335
Unraveled Material
206
206
Appropriate Term/Code Not Available
193
193
Component Missing
147
147
Insufficient Information
123
123
Patient Device Interaction Problem
122
122
Material Twisted/Bent
117
117
Product Quality Problem
109
109
Component Misassembled
102
102
Positioning Failure
95
95
Tear, Rip or Hole in Device Packaging
94
94
Defective Component
85
85
Dull, Blunt
77
77
Human-Device Interface Problem
71
71
Difficult to Open or Remove Packaging Material
70
70
Mechanical Problem
66
66
Delivered as Unsterile Product
66
66
Packaging Problem
57
57
Device Contaminated During Manufacture or Shipping
46
46
Device Appears to Trigger Rejection
46
46
Use of Device Problem
45
45
Device Slipped
42
42
Component or Accessory Incompatibility
36
36
Difficult to Remove
22
22
Component Incompatible
21
21
Material Deformation
21
21
Degraded
19
19
Material Discolored
18
18
Material Fragmentation
18
18
Entrapment of Device
15
15
Device Contamination with Chemical or Other Material
12
12
Fracture
11
11
Nonstandard Device
11
11
Positioning Problem
11
11
Material Too Soft/Flexible
9
9
Separation Problem
9
9
Inadequacy of Device Shape and/or Size
9
9
Defective Device
9
9
Biocompatibility
8
8
Loose or Intermittent Connection
8
130
Material Disintegration
7
7
Contamination /Decontamination Problem
7
7
Difficult to Open or Close
7
7
Device Misassembled During Manufacturing /Shipping
5
5
Material Protrusion/Extrusion
5
5
Separation Failure
5
5
Failure to Fire
5
5
Device Fell
5
249
Migration
5
5
Mechanics Altered
5
5
Therapeutic or Diagnostic Output Failure
4
4
Inaccurate Information
4
4
Missing Information
4
4
Sharp Edges
3
3
Disconnection
3
3
Unsealed Device Packaging
3
3
Material Too Rigid or Stiff
3
3
Leak/Splash
2
2
Migration or Expulsion of Device
2
2
Fluid/Blood Leak
2
2
Device Damaged Prior to Use
2
2
Structural Problem
2
2
Physical Resistance/Sticking
2
2
Loosening of Implant Not Related to Bone-Ingrowth
1
1
No Apparent Adverse Event
1
1
Noise, Audible
1
1
Unexpected Color
1
1
Extra Components
1
1
Failure to Advance
1
1
Expiration Date Error
1
1
Misfire
1
1
Improper or Incorrect Procedure or Method
1
1
Incomplete or Missing Packaging
1
1
Deformation Due to Compressive Stress
1
1
Mechanical Jam
1
1
Compatibility Problem
1
1
Activation, Positioning or Separation Problem
1
1
Device Dislodged or Dislocated
1
1
Expulsion
1
1
Labelling, Instructions for Use or Training Problem
1
1
Loss of or Failure to Bond
1
1
Material Erosion
1
1
Difficult or Delayed Positioning
1
1
Corroded
1
1
Collapse
1
1
Material Puncture/Hole
1
1
Material Rupture
1
1
Stretched
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
12722
12966
No Consequences Or Impact To Patient
4329
5444
Insufficient Information
1324
1324
Wound Dehiscence
1188
1188
Unspecified Infection
738
860
No Code Available
501
501
Inflammation
493
493
No Known Impact Or Consequence To Patient
461
461
Pain
440
562
Not Applicable
429
429
Post Operative Wound Infection
403
525
Foreign Body In Patient
375
497
Impaired Healing
318
440
Hemorrhage/Bleeding
310
554
Unspecified Tissue Injury
298
298
Unintended Radiation Exposure
253
253
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
236
236
No Patient Involvement
222
222
Abscess
193
193
Hematoma
182
182
Erythema
170
170
No Information
162
162
Fluid Discharge
162
162
Swelling/ Edema
143
143
Seroma
138
138
Failure to Anastomose
128
372
Pocket Erosion
124
124
Necrosis
120
120
Granuloma
119
119
Purulent Discharge
116
116
Hernia
108
108
Fistula
96
96
Scar Tissue
88
88
Foreign Body Reaction
84
84
Radiation Exposure, Unintended
84
84
Blood Loss
84
84
Obstruction/Occlusion
84
84
Hypersensitivity/Allergic reaction
83
83
Fever
82
82
Skin Inflammation/ Irritation
80
80
Device Embedded In Tissue or Plaque
79
79
Discomfort
64
64
Swelling
59
59
Urinary Tract Infection
57
57
Cellulitis
55
55
Local Reaction
51
51
Incontinence
51
51
Tissue Damage
41
41
Eye Injury
36
36
Itching Sensation
36
36
Sepsis
35
35
Patient Problem/Medical Problem
33
33
Bacterial Infection
32
32
Urinary Retention
31
31
Abdominal Pain
30
30
Erosion
25
25
Ulcer
22
22
Adhesion(s)
21
21
Cyst(s)
21
21
Laceration(s)
21
21
Peritonitis
20
20
Tissue Breakdown
19
19
Injury
18
18
Abnormal Vaginal Discharge
18
18
Rash
18
18
Skin Erosion
18
18
Vomiting
17
17
Stenosis
17
17
Eye Infections
17
17
Organ Dehiscence
17
17
Blister
16
16
Edema
15
15
Skin Irritation
13
13
Scarring
13
13
Skin Infection
13
13
Reaction
12
12
Anxiety
12
12
Chills
11
11
Perforation
11
11
Nausea
10
10
Visual Impairment
10
10
Cerebrospinal Fluid Leakage
10
10
Visual Disturbances
10
10
Hematuria
10
10
Ptosis
10
10
Abdominal Distention
9
9
Prolapse
9
9
Bowel Perforation
9
9
Anemia
9
9
Headache
8
8
Burning Sensation
8
8
Nerve Damage
7
7
Shock
7
7
Fatigue
7
7
Dysphagia/ Odynophagia
7
7
Muscle/Tendon Damage
7
7
Fibrosis
6
6
Multiple Organ Failure
6
6
Eye Pain
6
6
Numbness
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, LP
II
Nov-11-2022
4
Ethicon, Inc.
II
Apr-12-2024
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
Gordian Surgical
II
Nov-03-2020
11
Riverpoint Medical, LLC
II
Feb-03-2021
12
Riverpoint Medical, LLC
II
Oct-01-2020
13
SURGICAL SPECIALTIES
II
Apr-12-2024
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