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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, nonabsorbable
Regulation Description Stainless steel suture.
Product CodeGAO
Regulation Number 878.4495
Device Class 2

MDR Year MDR Reports MDR Events
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 20 20
Break 13 13
Fracture 4 4
Delivered as Unsterile Product 2 2
Unsealed Device Packaging 2 2
Material Separation 2 2
Entrapment of Device 1 1
Difficult to Remove 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
Inflammation 4 4
Pain 4 4
Foreign Body In Patient 3 3
Erythema 3 3
Skin Inflammation/ Irritation 3 3
Pocket Erosion 3 3
Abscess 3 3
Hemorrhage/Bleeding 2 2
Device Embedded In Tissue or Plaque 2 2
Swelling/ Edema 2 2
Wound Dehiscence 2 2
Unspecified Infection 2 2
Impaired Healing 2 2
Hypersensitivity/Allergic reaction 1 1
Fever 1 1
Necrosis 1 1
Itching Sensation 1 1
Fluid Discharge 1 1
No Consequences Or Impact To Patient 1 1
Obstruction/Occlusion 1 1
Purulent Discharge 1 1
Vertigo 1 1
Insufficient Information 1 1
Bacterial Infection 1 1
Blister 1 1
Ptosis 1 1
Sepsis 1 1
Vomiting 1 1
Rash 1 1
Post Operative Wound Infection 1 1
Eye Injury 1 1
Burning Sensation 1 1
Scar Tissue 1 1
Granuloma 1 1
Fistula 1 1
Ischemia Stroke 1 1

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