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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, absorbable
Product CodeGAK
Regulation Number 878.4830
Device Class 2

MDR Year MDR Reports MDR Events
2018 7 7
2019 24 24
2020 22 22
2021 13 13
2022 20 20
2023 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Break 49 49
Adverse Event Without Identified Device or Use Problem 49 49
Material Separation 11 11
Material Frayed 4 4
Appropriate Term/Code Not Available 3 3
Patient-Device Incompatibility 2 2
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
No Consequences Or Impact To Patient 24 24
Unspecified Infection 21 21
Pain 14 14
Insufficient Information 13 13
Not Applicable 13 13
Wound Dehiscence 11 11
Hemorrhage/Bleeding 9 9
Post Operative Wound Infection 7 7
Erythema 6 6
Inflammation 6 6
No Code Available 6 6
Impaired Healing 5 5
Hematoma 5 5
Pocket Erosion 4 4
Swelling/ Edema 4 4
Foreign Body In Patient 3 3
Scar Tissue 3 3
Urinary Retention 3 3
Failure to Anastomose 3 3
Fever 2 2
Death 2 2
Abscess 2 2
Swelling 2 2
Blood Loss 2 2
Abdominal Distention 2 2
Fluid Discharge 2 2
Hypersensitivity/Allergic reaction 2 2
Perforation 2 2
Incontinence 1 1
Sepsis 1 1
Seroma 1 1
Hernia 1 1
Deformity/ Disfigurement 1 1
Anaphylactic Shock 1 1
Bacterial Infection 1 1
Cellulitis 1 1
Purulent Discharge 1 1
Eye Injury 1 1
Fistula 1 1
Itching Sensation 1 1
Necrosis 1 1
No Known Impact Or Consequence To Patient 1 1
Obstruction/Occlusion 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1

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