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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, absorbable
Regulation Description Absorbable surgical gut suture.
Product CodeGAK
Regulation Number 878.4830
Device Class 2

MDR Year MDR Reports MDR Events
2016 23 23
2017 1 1
2018 7 7
2019 24 24
2020 22 22
2021 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 33 33
Adverse Event Without Identified Device or Use Problem 20 20
Product Quality Problem 19 19
Material Separation 5 5
Appropriate Term/Code Not Available 4 4
Material Frayed 4 4
Detachment Of Device Component 2 2
Material Integrity Problem 2 2
Detachment of Device or Device Component 2 2
Loss of or Failure to Bond 1 1
Patient-Device Incompatibility 1 1
Degraded 1 1
Unraveled Material 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 26 26
Skin Discoloration 19 19
Not Applicable 14 14
Unspecified Infection 10 10
Pain 8 8
No Clinical Signs, Symptoms or Conditions 8 8
Wound Dehiscence 6 6
No Code Available 6 6
Erythema 4 4
Inflammation 4 4
Hematoma 3 3
Scar Tissue 3 3
Impaired Healing 3 3
Post Operative Wound Infection 2 2
Blood Loss 2 2
Death 2 2
Fever 2 2
Abscess 2 2
Failure to Anastomose 2 2
Abdominal Distention 2 2
Swelling 2 2
Deformity/ Disfigurement 1 1
No Known Impact Or Consequence To Patient 1 1
Hypersensitivity/Allergic reaction 1 1
Sepsis 1 1
Foreign Body In Patient 1 1
Skin Inflammation/ Irritation 1 1
No Information 1 1

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