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TPLC
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Device
suture, nonabsorbable, silk
Regulation Description
Natural nonabsorbable silk surgical suture.
Product Code
GAP
Regulation Number
878.5030
Device Class
2
Premarket Reviews
Manufacturer
Decision
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
HUAIAN SEAMEN MEDICAL TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SAFEPATH MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
426
426
2021
437
437
2022
419
419
2023
404
404
2024
455
455
2025
35
35
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1210
1210
Adverse Event Without Identified Device or Use Problem
317
317
Material Separation
254
254
Detachment of Device or Device Component
110
110
Material Split, Cut or Torn
92
92
Delivered as Unsterile Product
43
43
Device Contaminated During Manufacture or Shipping
33
33
Manufacturing, Packaging or Shipping Problem
28
28
Component Misassembled
25
25
Biocompatibility
17
17
Packaging Problem
16
16
Material Frayed
16
16
Device Markings/Labelling Problem
15
15
Nonstandard Device
12
12
Material Integrity Problem
10
10
Defective Component
10
10
Material Discolored
7
7
Product Quality Problem
6
6
Component Missing
5
5
Material Twisted/Bent
5
5
Appropriate Term/Code Not Available
5
5
Patient-Device Incompatibility
5
5
Insufficient Information
4
4
Migration
3
3
Dull, Blunt
3
3
Difficult to Remove
2
2
Use of Device Problem
2
2
Contamination /Decontamination Problem
2
2
Mechanical Problem
2
2
Mechanics Altered
2
2
Difficult to Open or Remove Packaging Material
2
2
Corroded
1
1
Unraveled Material
1
1
Illegible Information
1
1
Device Slipped
1
1
Device Contamination with Chemical or Other Material
1
1
No Apparent Adverse Event
1
1
Patient Device Interaction Problem
1
1
Tear, Rip or Hole in Device Packaging
1
1
Fracture
1
1
Component Incompatible
1
1
Material Too Rigid or Stiff
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1434
1434
No Consequences Or Impact To Patient
232
232
Inflammation
169
169
Erythema
123
123
Swelling/ Edema
93
93
Unspecified Infection
84
84
Pain
83
83
Fluid Discharge
82
82
Insufficient Information
82
82
Hemorrhage/Bleeding
65
65
Purulent Discharge
45
45
Skin Inflammation/ Irritation
40
40
Wound Dehiscence
40
40
Itching Sensation
34
34
Hypersensitivity/Allergic reaction
33
33
Not Applicable
32
32
No Known Impact Or Consequence To Patient
32
32
Impaired Healing
31
31
Post Operative Wound Infection
19
19
Pocket Erosion
17
17
Foreign Body In Patient
13
13
Foreign Body Reaction
11
11
Fistula
11
11
Granuloma
10
10
Fever
10
10
Unspecified Tissue Injury
9
9
Local Reaction
9
9
Abscess
9
9
No Information
8
8
No Code Available
8
8
Discomfort
7
7
Blood Loss
7
7
Failure to Anastomose
6
6
Necrosis
6
6
Unintended Radiation Exposure
6
6
Scar Tissue
5
5
Ulcer
4
4
Hernia
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Bacterial Infection
3
3
Cyst(s)
3
3
Obstruction/Occlusion
3
3
Eye Injury
3
3
Burning Sensation
3
3
Sepsis
3
3
Pneumothorax
3
3
Skin Tears
2
2
Abdominal Distention
2
2
Ptosis
2
2
No Patient Involvement
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien LP
II
Jan-29-2024
2
Covidien, LP
II
Apr-29-2024
3
Covidien, LP
II
Feb-25-2023
4
Ethicon, Inc.
II
Jul-02-2020
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