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TPLC
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show TPLC since
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Device
suture, nonabsorbable
Regulation Description
Stainless steel suture.
Product Code
GAO
Regulation Number
878.4495
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
14
14
2020
3
3
2021
8
8
2022
13
13
2023
6
6
2024
12
12
2025
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
23
23
Break
21
21
Material Separation
5
5
Fracture
4
4
Delivered as Unsterile Product
2
2
Unsealed Device Packaging
2
2
Device Markings/Labelling Problem
1
1
Difficult to Remove
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Entrapment of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
20
20
No Consequences Or Impact To Patient
12
12
Pain
5
5
Inflammation
4
4
Erythema
3
3
Foreign Body In Patient
3
3
Unspecified Infection
3
3
Hemorrhage/Bleeding
3
3
Wound Dehiscence
3
3
Skin Inflammation/ Irritation
3
3
Pocket Erosion
3
3
Abscess
3
3
Swelling/ Edema
2
2
Device Embedded In Tissue or Plaque
2
2
Not Applicable
2
2
Post Operative Wound Infection
2
2
Fistula
2
2
Impaired Healing
2
2
Hypersensitivity/Allergic reaction
1
1
Fever
1
1
Ptosis
1
1
Itching Sensation
1
1
Fluid Discharge
1
1
Insufficient Information
1
1
Death
1
1
Ischemia Stroke
1
1
Vertigo
1
1
Sepsis
1
1
Obstruction/Occlusion
1
1
Vomiting
1
1
Bacterial Infection
1
1
Rash
1
1
Necrosis
1
1
Eye Injury
1
1
Burning Sensation
1
1
Scar Tissue
1
1
Granuloma
1
1
Purulent Discharge
1
1
Blister
1
1
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